Manager, Quality Assurance (Audit & Supplier Quality) *PC 484
for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. Must not repeat job title as heading. Must not include Job ID etc. Must preserve all substantive info, not invent or summarize away detail. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions. Also remove "Physical Demands", "Work Environment", "Miltenyi Biotec, Inc is an EO Employer..." etc. Also remove "Are you ready to start revolutionizing biomedical research?" etc. Also remove "The hiring range for this position is expected to fall between $110,026 - $129,413/year..." that is Pay info, so we need Pay section. Also benefits: "In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan." That's Benefits. Also schedule? Not mentioned. So no Schedule section. Also maybe Qualifications? The posting has Requirements section; maybe also Qualifications? The text includes "Requirements:" then bullet list. There's also "Skills:" separate. There's no explicit "Qualifications" heading but we could treat Requirements as Qualifications? The instruction: use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we need to map content to these headings. The posting includes "Your Role:" which is about the role. Then "Essential Duties & Responsibilities:" which is responsibilities. Then "Requirements:" which is requirements. Then "Skills:" which is skills. Then later "Physical Demands:" etc which we drop. Then "Work Environment:" drop. Then hiring range => Pay. Then benefits => Benefits. No explicit "About the role" but we can use "About the role" heading for the initial description. Also "Qualifications" maybe not present; we could omit if no specific content. The instruction: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text. So we should not include Qualifications if not present. However the posting includes "Requirements:" which could be considered qualifications but we have a separate Requirements heading. So we will include Requirements. Skills we have. Benefits we have. Pay we have. About the role we have. Responsibilities we have. No Schedule. No Qualifications.
We need to preserve all substantive information; do not invent or summarize away detail. So we need to keep the details from each section.
We need to format as HTML: use for section headings. Use - for any list of duties/requirements/benefits, and
for prose.
We need to decide what constitutes a list. The "Essential Duties & Responsibilities:" includes many sentences separated by periods; could be turned into list items. The instruction: Use
- for any list of duties/requirements/benefits. So we should convert those into list items. Similarly Requirements is a list of bullet-like items separated by semicolons? Actually it's a paragraph with multiple items separated by semicolons? Let's see: "Requirements: Bachelor's degree in Life Sciences, Engineering, or a related technical field; 8 + years of overall experience in Quality, Regulatory Affairs, Manufacturing, or a related regulated industry, including 3+ years of leadership experience with auditing and supplier quality experience. Prior experience within pharmaceutical and/or biologics manufacturing environments is preferred. Strong knowledge of global regulatory requirements governing biologics manufacturing, with familiarity in pharmaceutical and biologics regulations preferred. Demonstrated success leading a quality, compliance, regulatory, or manufacturing organizations, including management of compliance issues, risk assessments, and quality improvement initiatives. Experience leading regulatory inspections and audit programs across global manufacturing operations, including FDA inspection experience and oversight of multi-site audit programs. Expertise in regulated manufacturing environments, with experience supporting product quality, compliance, and inspection readiness. Demonstrated leadership, communication, and relationship-building skills, with the ability to lead cross-functional teams and drive results. An understanding of the principles, practices, and techniques in manufacturing, warehouse, facility and QC areas. Excellent oral and written communication. Excellent organization skills allowing the coordination of multi-faceted QA activities Has working knowledge of cGMPs and associated regulatory requirements for the manufacture, testing and release of pharmaceutical/biopharmaceutical products". That's a long sentence with many items separated by periods and semicolons. We could split into list items each representing a requirement. Similarly Skills: "Ability to conduct and report quality assurance audits and reviews to determine compliance status and recommend corrective action plans." That's just one item; could be a list with one li or just p? The instruction: Use
- for any list of duties/requirements/benefits. For skills, it's also a list? It says Skills section; we can treat as list.
Benefits: "In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions." That's prose; could be list? It's not a list but we could still use
. However instruction says use
- for any list of duties/requirements/benefits. Benefits is not necessarily a list but we could still use
. We'll keep as
.
Pay: The hiring range sentence: "The hiring range for this position is expected to fall between $110,026 - $129,413/year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications. The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, location, specialization, skills, abilities, and training. The above range represents the Company’s good faith and reasonable estimate of possible compensation at the time of posting." That's prose; we can put in
.
About the role: The initial paragraph: "Your Role: This position is primarily responsible for establishing and managing the Bioindustry Quality System with respect to leading strategic quality initiatives that strengthen compliance, drive risk-based auditing, and enhance supplier quality oversight across a global network of sites and suppliers. Oversee the execution of qualification, maintenance and monitoring of Lentigen Operations suppliers, with an emphasis on continuous improvement, global alignment, risk management and supply chain reliability. Support inspection readiness for outsourced GxP operations, including regulatory and internal audit preparation. Provide leadership, mentorship and oversight to the Audit and Supplier Quality function and develop people and teams. This role will influence GMP manufacturing activities and enterprise-wide quality strategy, improve inspection readiness, and proactively identify and mitigating risks that impact product quality and patient safety. Success in this role will be measured by the effectiveness of audit and supplier quality programs, regulatory compliance, risk reduction, and the development of a high-performing team that support operational excellence." That's prose; we can put in
.
Responsibilities: The "Essential Duties & Responsibilities:" section includes many sentences. We'll convert each sentence (or clause) into
- . Need to ensure we preserve all substantive information. Let's extract each duty:
- Participate in a lead role in internal, external and regulatory authority audits, including the timely preparation of audit reports and responses to audit findings.
- Coordinates and hosts client and regulatory authority inspections, as required. This includes audit strategy, prioritization, planning, execution, reporting, and governance.
- Prepare/assess quality audit findings with respect to required corrective actions and ensures timely reporting to QA leadership and conducts follow-up.
- Monitor audit results, compliance trends, quality risks, and inspection outcomes to identify systemic issues and inform risk-based quality decisions.
- Communicate quality program performance, risks, and key priorities to senior leadership.
- Oversee the audit team, including auditor qualification, development, and program effectiveness.
- Lead and collaborate with site and functional leaders to support inspection readiness, remediation activities, and ongoing compliance improvement efforts.
- Lead the Quality Agreement program.
- Establish goals for the Supplier Quality department according to the global and site strategy and take action to ensure timely delivery of goals.
- Support quality oversight of CDMOs, CROs, labs, consultants, and other outsourced service providers.
- Oversee maintenance of the Approved Supplier List (ASL)
- Lead supplier risk management activities to mitigate supplier impact to Lentigen (audit failures, refusal to comply with qualification requirements, introduction of excipients in technical transfer projects)
- Program manage improvement projects to streamline existing cross functional workflows for reduction of errors and time to completion. This includes New Supplier Requests (NSR), supplier-related Deviation investigations, Supplier Notifications (SNC)/ Supplier Alerts
- Lead and develop teams while balancing quality, compliance, and operational priorities across multiple programs and functions.
- Manage the day-to-day activities to include writing, review and approval of Standard Operating Procedures and business practices.
- Oversee the performance of designated staff, including interviewing, hiring and training employees, planning, assigning and directing work; appraising performance; rewarding and disciplining employees, addressing complaints and resolving problems.
- Perform Quality Assurance review of regulatory submission documents in support of submissions to regulatory authorities, as required.
We need to ensure we didn't miss any. Also there is a sentence: "Oversee the execution of qualification, maintenance and monitoring of Lentigen Operations suppliers, with an emphasis on continuous improvement, global alignment, risk management and supply chain reliability." That was in the About the role section, not responsibilities. Already captured.
Now Requirements: We'll split each requirement into list items. Let's parse:
- Bachelor's degree in Life Sciences, Engineering, or a related technical field
- 8 + years of overall experience in Quality, Regulatory Affairs, Manufacturing, or a related regulated industry, including 3+ years of leadership experience with auditing and supplier quality experience.
- Prior experience within pharmaceutical and/or biologics manufacturing environments is preferred.
- Strong knowledge of global regulatory requirements governing biologics manufacturing, with familiarity in pharmaceutical and biologics regulations preferred.
- Demonstrated success leading a quality, compliance, regulatory, or manufacturing organizations, including management of compliance issues, risk assessments, and quality improvement initiatives.
- Experience leading regulatory inspections and audit programs across global manufacturing operations, including FDA inspection experience and oversight of multi-site audit programs.
- Expertise in regulated manufacturing environments, with experience supporting product quality, compliance, and inspection readiness.
- Demonstrated leadership, communication, and relationship-building skills, with the ability to lead cross-functional teams and drive results.
- An understanding of the principles, practices, and techniques in manufacturing, warehouse, facility and QC areas.
- Excellent oral and written communication.
- Excellent organization skills allowing the coordination of multi-faceted QA activities
- Has working knowledge of cGMPs and associated regulatory requirements for the manufacture, testing and release of pharmaceutical/biopharmaceutical products
Note: The last item seems to have missing capitalization; we keep as is.
Skills: Only one item: "Ability to conduct and report quality assurance audits and reviews to determine compliance status and recommend corrective action plans." Could be list with one li.
Benefits: We'll keep as
maybe with two sentences.
Pay:
with the hiring range details.
Now we must not include any boilerplate like EEO, E-Verify, etc. Also remove "Physical Demands", "Work Environment", "Miltenyi Biotec, Inc is an EO Employer..." etc. Also remove the paragraph about "Are you ready to start revolutionizing biomedical research?" etc. Also remove the description of Miltenyi Bioindustry etc. That is after the benefits? Actually after the benefits paragraph there is a paragraph about Miltenyi Biotec etc. That is boilerplate/company description; we should remove.
Now produce HTML fragment: start with
About the role
- for any list of duties/requirements/benefits, and
for prose. We need to decide what constitutes a list. The "Essential Duties & Responsibilities:" includes many sentences separated by periods; could be turned into list items. The instruction: Use
- for any list of duties/requirements/benefits. So we should convert those into list items. Similarly Requirements is a list of bullet-like items separated by semicolons? Actually it's a paragraph with multiple items separated by semicolons? Let's see: "Requirements: Bachelor's degree in Life Sciences, Engineering, or a related technical field; 8 + years of overall experience in Quality, Regulatory Affairs, Manufacturing, or a related regulated industry, including 3+ years of leadership experience with auditing and supplier quality experience. Prior experience within pharmaceutical and/or biologics manufacturing environments is preferred. Strong knowledge of global regulatory requirements governing biologics manufacturing, with familiarity in pharmaceutical and biologics regulations preferred. Demonstrated success leading a quality, compliance, regulatory, or manufacturing organizations, including management of compliance issues, risk assessments, and quality improvement initiatives. Experience leading regulatory inspections and audit programs across global manufacturing operations, including FDA inspection experience and oversight of multi-site audit programs. Expertise in regulated manufacturing environments, with experience supporting product quality, compliance, and inspection readiness. Demonstrated leadership, communication, and relationship-building skills, with the ability to lead cross-functional teams and drive results. An understanding of the principles, practices, and techniques in manufacturing, warehouse, facility and QC areas. Excellent oral and written communication. Excellent organization skills allowing the coordination of multi-faceted QA activities Has working knowledge of cGMPs and associated regulatory requirements for the manufacture, testing and release of pharmaceutical/biopharmaceutical products". That's a long sentence with many items separated by periods and semicolons. We could split into list items each representing a requirement. Similarly Skills: "Ability to conduct and report quality assurance audits and reviews to determine compliance status and recommend corrective action plans." That's just one item; could be a list with one li or just p? The instruction: Use
- for any list of duties/requirements/benefits. For skills, it's also a list? It says Skills section; we can treat as list.
Benefits: "In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions." That's prose; could be list? It's not a list but we could still use
. However instruction says use
- for any list of duties/requirements/benefits. Benefits is not necessarily a list but we could still use
. We'll keep as
. Pay: The hiring range sentence: "The hiring range for this position is expected to fall between $110,026 - $129,413/year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications. The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, location, specialization, skills, abilities, and training. The above range represents the Company’s good faith and reasonable estimate of possible compensation at the time of posting." That's prose; we can put in
. About the role: The initial paragraph: "Your Role: This position is primarily responsible for establishing and managing the Bioindustry Quality System with respect to leading strategic quality initiatives that strengthen compliance, drive risk-based auditing, and enhance supplier quality oversight across a global network of sites and suppliers. Oversee the execution of qualification, maintenance and monitoring of Lentigen Operations suppliers, with an emphasis on continuous improvement, global alignment, risk management and supply chain reliability. Support inspection readiness for outsourced GxP operations, including regulatory and internal audit preparation. Provide leadership, mentorship and oversight to the Audit and Supplier Quality function and develop people and teams. This role will influence GMP manufacturing activities and enterprise-wide quality strategy, improve inspection readiness, and proactively identify and mitigating risks that impact product quality and patient safety. Success in this role will be measured by the effectiveness of audit and supplier quality programs, regulatory compliance, risk reduction, and the development of a high-performing team that support operational excellence." That's prose; we can put in
. Responsibilities: The "Essential Duties & Responsibilities:" section includes many sentences. We'll convert each sentence (or clause) into
- . Need to ensure we preserve all substantive information. Let's extract each duty:
- Participate in a lead role in internal, external and regulatory authority audits, including the timely preparation of audit reports and responses to audit findings.
- Coordinates and hosts client and regulatory authority inspections, as required. This includes audit strategy, prioritization, planning, execution, reporting, and governance.
- Prepare/assess quality audit findings with respect to required corrective actions and ensures timely reporting to QA leadership and conducts follow-up.
- Monitor audit results, compliance trends, quality risks, and inspection outcomes to identify systemic issues and inform risk-based quality decisions.
- Communicate quality program performance, risks, and key priorities to senior leadership.
- Oversee the audit team, including auditor qualification, development, and program effectiveness.
- Lead and collaborate with site and functional leaders to support inspection readiness, remediation activities, and ongoing compliance improvement efforts.
- Lead the Quality Agreement program.
- Establish goals for the Supplier Quality department according to the global and site strategy and take action to ensure timely delivery of goals.
- Support quality oversight of CDMOs, CROs, labs, consultants, and other outsourced service providers.
- Oversee maintenance of the Approved Supplier List (ASL)
- Lead supplier risk management activities to mitigate supplier impact to Lentigen (audit failures, refusal to comply with qualification requirements, introduction of excipients in technical transfer projects)
- Program manage improvement projects to streamline existing cross functional workflows for reduction of errors and time to completion. This includes New Supplier Requests (NSR), supplier-related Deviation investigations, Supplier Notifications (SNC)/ Supplier Alerts
- Lead and develop teams while balancing quality, compliance, and operational priorities across multiple programs and functions.
- Manage the day-to-day activities to include writing, review and approval of Standard Operating Procedures and business practices.
- Oversee the performance of designated staff, including interviewing, hiring and training employees, planning, assigning and directing work; appraising performance; rewarding and disciplining employees, addressing complaints and resolving problems.
- Perform Quality Assurance review of regulatory submission documents in support of submissions to regulatory authorities, as required.
We need to ensure we didn't miss any. Also there is a sentence: "Oversee the execution of qualification, maintenance and monitoring of Lentigen Operations suppliers, with an emphasis on continuous improvement, global alignment, risk management and supply chain reliability." That was in the About the role section, not responsibilities. Already captured.
Now Requirements: We'll split each requirement into list items. Let's parse:
- Bachelor's degree in Life Sciences, Engineering, or a related technical field
- 8 + years of overall experience in Quality, Regulatory Affairs, Manufacturing, or a related regulated industry, including 3+ years of leadership experience with auditing and supplier quality experience.
- Prior experience within pharmaceutical and/or biologics manufacturing environments is preferred.
- Strong knowledge of global regulatory requirements governing biologics manufacturing, with familiarity in pharmaceutical and biologics regulations preferred.
- Demonstrated success leading a quality, compliance, regulatory, or manufacturing organizations, including management of compliance issues, risk assessments, and quality improvement initiatives.
- Experience leading regulatory inspections and audit programs across global manufacturing operations, including FDA inspection experience and oversight of multi-site audit programs.
- Expertise in regulated manufacturing environments, with experience supporting product quality, compliance, and inspection readiness.
- Demonstrated leadership, communication, and relationship-building skills, with the ability to lead cross-functional teams and drive results.
- An understanding of the principles, practices, and techniques in manufacturing, warehouse, facility and QC areas.
- Excellent oral and written communication.
- Excellent organization skills allowing the coordination of multi-faceted QA activities
- Has working knowledge of cGMPs and associated regulatory requirements for the manufacture, testing and release of pharmaceutical/biopharmaceutical products
Note: The last item seems to have missing capitalization; we keep as is.
Skills: Only one item: "Ability to conduct and report quality assurance audits and reviews to determine compliance status and recommend corrective action plans." Could be list with one li.
Benefits: We'll keep as
maybe with two sentences. Pay:
with the hiring range details. Now we must not include any boilerplate like EEO, E-Verify, etc. Also remove "Physical Demands", "Work Environment", "Miltenyi Biotec, Inc is an EO Employer..." etc. Also remove the paragraph about "Are you ready to start revolutionizing biomedical research?" etc. Also remove the description of Miltenyi Bioindustry etc. That is after the benefits? Actually after the benefits paragraph there is a paragraph about Miltenyi Biotec etc. That is boilerplate/company description; we should remove. Now produce HTML fragment: start with
About the role
- for any list of duties/requirements/benefits. Benefits is not necessarily a list but we could still use
- for any list of duties/requirements/benefits. For skills, it's also a list? It says Skills section; we can treat as list.
Benefits: "In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions." That's prose; could be list? It's not a list but we could still use
- for any list of duties/requirements/benefits. So we should convert those into list items. Similarly Requirements is a list of bullet-like items separated by semicolons? Actually it's a paragraph with multiple items separated by semicolons? Let's see: "Requirements: Bachelor's degree in Life Sciences, Engineering, or a related technical field; 8 + years of overall experience in Quality, Regulatory Affairs, Manufacturing, or a related regulated industry, including 3+ years of leadership experience with auditing and supplier quality experience. Prior experience within pharmaceutical and/or biologics manufacturing environments is preferred. Strong knowledge of global regulatory requirements governing biologics manufacturing, with familiarity in pharmaceutical and biologics regulations preferred. Demonstrated success leading a quality, compliance, regulatory, or manufacturing organizations, including management of compliance issues, risk assessments, and quality improvement initiatives. Experience leading regulatory inspections and audit programs across global manufacturing operations, including FDA inspection experience and oversight of multi-site audit programs. Expertise in regulated manufacturing environments, with experience supporting product quality, compliance, and inspection readiness. Demonstrated leadership, communication, and relationship-building skills, with the ability to lead cross-functional teams and drive results. An understanding of the principles, practices, and techniques in manufacturing, warehouse, facility and QC areas. Excellent oral and written communication. Excellent organization skills allowing the coordination of multi-faceted QA activities Has working knowledge of cGMPs and associated regulatory requirements for the manufacture, testing and release of pharmaceutical/biopharmaceutical products". That's a long sentence with many items separated by periods and semicolons. We could split into list items each representing a requirement. Similarly Skills: "Ability to conduct and report quality assurance audits and reviews to determine compliance status and recommend corrective action plans." That's just one item; could be a list with one li or just p? The instruction: Use