Director, Quality
for each section heading. Use - for lists. Use
for prose.
We need to preserve all substantive info, not invent. Remove boilerplate like mission statement? The mission statement is substantive? It says "Our mission is to inspire advances..." That's maybe part of About the role? Could include as paragraph.
We need to include all responsibilities listed. Let's extract responsibilities:
- Lead the Quality Operations and Incoming Quality Control teams that support both manufacturing and distribution.
- Oversee the site's ISO 9001 Quality Management System.
- Build strong partnerships across the organization.
- Drive a culture of quality, continuous improvement, and accountability.
- Mentor and develop a high-performing team while ensuring compliance, supporting business growth, and helping teams solve complex quality challenges.
- Model Leadership Behaviors (list).
- Maintain compliance to ISO 9001 for all aspects of the QMS including, but not limited to, Internal and External Auditing, Nonconforming Materials, CAPA, Validation, Complaint Handling, Change Controls, and other product lifecycle management activities, while promoting a culture of quality, accountability, and continuous improvement.
- Partner with cross-functional stakeholders to drive continuous improvement initiatives and support achievement of shared business objectives.
- Author and revise procedures and specifications in collaboration with subject matter experts to ensure clarity, effectiveness, and regulatory compliance.
- Ensure effective training and adoption of quality systems and procedures across the organization.
- Foster a strong cross-functional quality mindset and influence quality ownership at all levels of the organization.
- Effectively communicate sound quality guidance based on regulatory requirements, customer expectations, and business needs, balancing strategic priorities with operational execution.
- Apply quality knowledge strategically and operationally across projects within a matrix environment, demonstrating strong negotiation, influence, and facilitation skills.
- Demonstrate strong organizational skills with the ability to effectively multitask, prioritize, and drive results in a dynamic environment.
- Adapt to changing business needs while maintaining focus on quality, compliance, and execution of key deliverables.
- Exercise sound judgment, initiative, and problem-solving skills to proactively identify and address quality-related risks.
- Serve as the Management Representative to the ISO 9001 registrar.
- Develop, monitor, and compile quality metrics to support monthly KPI reporting and management review meetings, leveraging data to drive informed decision-making and continuous improvement.
- Facilitate operational excellence initiatives within Quality Assurance to improve efficiency, effectiveness, and overall quality performance.
- Maintain internal and external audit schedules and ensure audit readiness across the organization.
- Maintain a risk-based strategy for overall quality compliance and continuous improvement in support of ISO 9001 requirements.
- Collaborate closely with Global Supplier Quality to ensure timely investigation and remediation of supplier material issues, fostering strong internal and external partnerships.
- Review and approve validation plans, deviations, failure investigations, and corrective action plans prior to implementation, ensuring appropriate risk assessment and compliance.
- Assist with OOS investigations, OOT investigations, and NCMR investigations, promoting thorough root cause analysis and sustainable corrective actions.
- Complete required actions associated with identified corrective and preventive actions for the Quality department in a timely and effective manner.
- Lead, mentor, and develop direct reports by setting clear objectives, providing ongoing coaching and feedback, and supporting professional growth and team success.
Qualifications:
- Bachelor's degree in Engineering, Biology, or Chemistry required.
- Minimum of 10 years of experience in a cGMP, ISO 13485, or ISO 9001 Quality Management System environment required.
- Minimum of 5-8 years of experience mentoring, developing, and supervising direct reports.
- Excellent verbal and written communication skills with the ability to influence and build strong working relationships across functions.
- Strong attention to detail and commitment to quality and compliance.
- Collaborative team player who effectively partners across departments to achieve common goals and drive business success.
- ASQ CQA and/or CQE certification preferred.
- Experience with LEAN implementation strongly preferred.
- Demonstrated ability to foster and sustain a Quality Culture across the organization through leadership, engagement, and accountability.
- Demonstrated ability to mentor, train, coach, and develop quality professionals while building a high-performing and engaged team.
Skills: maybe we can combine some of the qualifications that are skill-based: communication, influence, organizational, multitask, problem solving, negotiation, influence, facilitation, etc. But we can just put a Skills section listing those.
Benefits: paid time off, health/dental/vision, retirement benefits, flexible spending accounts.
Pay: estimated base salary range $180,000 - $230,000. Also mention variable cash programs (bonus or commission) and equity eligibility. We'll include that.
Schedule: none, so omit.
About the role: maybe a paragraph summarizing role: "We are seeking an experienced Quality Leader to join our Repligen Shrewsbury, MA facility. The Shrewsbury site includes both a manufacturing operation and distribution center, and this role will lead the Quality Operations and Incoming Quality Control teams that support both functions. The Director of Quality will oversee the site's ISO 9001 Quality Management System, build strong partnerships across the organization, and drive a culture of quality, continuous improvement, and accountability. This individual will mentor and develop a high-performing team while ensuring compliance, supporting business growth, and helping teams solve complex quality challenges. This role is expected to model our Leadership Behaviors—Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results—in all aspects of work." plus mission statement maybe.
We must not repeat job title as heading. The job title is "Quality Leader" or "Director of Quality"? The posting says "We are seeking an experienced Quality Leader". We'll not repeat.
Now produce HTML fragment.
We need to ensure we don't include any extra text outside HTML. No markdown fences.
Let's craft.
Structure:
About the role
...
Responsibilities
- ...
...
Qualifications
- ...
...
Skills
- ...
...
Benefits
- Paid time off
- Health, dental, and vision insurance
- Retirement benefits
- Flexible spending accounts
Pay
The estimated base salary range for this role is $180,000 – $230,000. Employees are eligible to participate in variable cash programs (bonus or commission) and may receive equity as part of the compensation package.
We need to ensure we don't include any boilerplate like "All compensation and benefits information will be confirmed in writing at the time of offer." That's somewhat generic but maybe we can keep as it's substantive? It's a statement about confirmation; could be considered boilerplate but it's about compensation details. Might be okay to keep but it's not required. The instruction: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. That line is not exactly those; it's about compensation confirmation. Might be okay to keep but we can omit to keep concise. We'll keep only salary range and variable cash/equity.
Now ensure we preserve all substantive info from responsibilities and qualifications. Let's list them precisely.
Responsibilities list items (I'll condense but keep meaning):
- Lead the Quality Operations and Incoming Quality Control teams supporting manufacturing and distribution.
- Oversee the site's ISO 9001 Quality Management System.
- Build strong partnerships across the organization.
- Drive a culture of quality, continuous improvement, and accountability.
- Mentor and develop a high‑performing team while ensuring compliance, supporting business growth, and helping teams solve complex quality challenges.
- Model the Leadership Behaviors (Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, Accountability & Results) in all work.
- Maintain compliance to ISO 9001 for all aspects of the QMS including internal and external auditing, nonconforming materials, CAPA, validation, complaint handling, change controls, and other product lifecycle management activities, while promoting a culture of quality, accountability, and continuous improvement.
- Partner with cross‑functional stakeholders to drive continuous improvement initiatives and support achievement of shared business objectives.
- Author and revise procedures and specifications with subject‑matter experts to ensure clarity, effectiveness, and regulatory compliance.
- Ensure effective training and adoption of quality systems and procedures across the organization.
- Foster a strong cross‑functional quality mindset and influence quality ownership at all levels.
- Effectively communicate sound quality guidance based on regulatory requirements, customer expectations, and business needs, balancing strategic priorities with operational execution.
- Apply quality knowledge strategically and operationally across projects in a matrix environment, demonstrating strong negotiation, influence, and facilitation skills.
- Demonstrate strong organizational skills with the ability to multitask, prioritize, and drive results in a dynamic environment.
- Adapt to changing business needs while maintaining focus on quality, compliance, and execution of key deliverables.
- Exercise sound judgment, initiative, and problem‑solving skills to proactively identify and address quality‑related risks.
- Serve as the Management Representative to the ISO 9001 registrar.
- Develop, monitor, and compile quality metrics to support monthly KPI reporting and management review meetings, leveraging data for informed decision‑making and continuous improvement.
- Facilitate operational excellence initiatives within Quality Assurance to improve efficiency, effectiveness, and overall quality performance.
- Maintain internal and external audit schedules and ensure audit readiness across the organization.
- Maintain a risk‑based strategy for overall quality compliance and continuous improvement in support of ISO 9001 requirements.
- Collaborate closely with Global Supplier Quality to ensure timely investigation and remediation of supplier material issues, fostering strong internal and external partnerships.
- Review and approve validation plans, deviations, failure investigations, and corrective action plans prior to implementation, ensuring appropriate risk assessment and compliance.
- Assist with OOS, OOT, and NCMR investigations, promoting thorough root cause analysis and sustainable corrective actions.
- Complete required actions associated with identified corrective and preventive actions for the Quality department in a timely and effective manner.
- Lead, mentor, and develop direct reports by setting clear objectives, providing ongoing coaching and feedback, and supporting professional growth and team success.
Qualifications list:
- Bachelor's degree in Engineering, Biology, or Chemistry required.
- Minimum of 10 years of experience in a cGMP, ISO 13485, or ISO 9001 Quality Management System environment required.
- Minimum of 5‑8 years of experience mentoring, developing, and supervising direct reports.
- Excellent verbal and written communication skills with the ability to influence and build strong working relationships across functions.
- Strong attention to detail and commitment to quality and compliance.
- Collaborative team player who effectively partners across departments to achieve common goals and drive business success.
- ASQ CQA and/or CQE certification preferred.
- Experience with LEAN implementation strongly preferred.
- Demonstrated ability to foster and sustain a Quality Culture across the organization through leadership, engagement, and accountability.
- Demonstrated ability to mentor, train, coach, and develop quality professionals while building a high‑performing and engaged team.
Skills list: we can extract skill-based items from qualifications and responsibilities: communication, influence, relationship building, organizational, multitasking, prioritization, problem solving
for prose. We need to preserve all substantive info, not invent. Remove boilerplate like mission statement? The mission statement is substantive? It says "Our mission is to inspire advances..." That's maybe part of About the role? Could include as paragraph. We need to include all responsibilities listed. Let's extract responsibilities: - Lead the Quality Operations and Incoming Quality Control teams that support both manufacturing and distribution. - Oversee the site's ISO 9001 Quality Management System. - Build strong partnerships across the organization. - Drive a culture of quality, continuous improvement, and accountability. - Mentor and develop a high-performing team while ensuring compliance, supporting business growth, and helping teams solve complex quality challenges. - Model Leadership Behaviors (list). - Maintain compliance to ISO 9001 for all aspects of the QMS including, but not limited to, Internal and External Auditing, Nonconforming Materials, CAPA, Validation, Complaint Handling, Change Controls, and other product lifecycle management activities, while promoting a culture of quality, accountability, and continuous improvement. - Partner with cross-functional stakeholders to drive continuous improvement initiatives and support achievement of shared business objectives. - Author and revise procedures and specifications in collaboration with subject matter experts to ensure clarity, effectiveness, and regulatory compliance. - Ensure effective training and adoption of quality systems and procedures across the organization. - Foster a strong cross-functional quality mindset and influence quality ownership at all levels of the organization. - Effectively communicate sound quality guidance based on regulatory requirements, customer expectations, and business needs, balancing strategic priorities with operational execution. - Apply quality knowledge strategically and operationally across projects within a matrix environment, demonstrating strong negotiation, influence, and facilitation skills. - Demonstrate strong organizational skills with the ability to effectively multitask, prioritize, and drive results in a dynamic environment. - Adapt to changing business needs while maintaining focus on quality, compliance, and execution of key deliverables. - Exercise sound judgment, initiative, and problem-solving skills to proactively identify and address quality-related risks. - Serve as the Management Representative to the ISO 9001 registrar. - Develop, monitor, and compile quality metrics to support monthly KPI reporting and management review meetings, leveraging data to drive informed decision-making and continuous improvement. - Facilitate operational excellence initiatives within Quality Assurance to improve efficiency, effectiveness, and overall quality performance. - Maintain internal and external audit schedules and ensure audit readiness across the organization. - Maintain a risk-based strategy for overall quality compliance and continuous improvement in support of ISO 9001 requirements. - Collaborate closely with Global Supplier Quality to ensure timely investigation and remediation of supplier material issues, fostering strong internal and external partnerships. - Review and approve validation plans, deviations, failure investigations, and corrective action plans prior to implementation, ensuring appropriate risk assessment and compliance. - Assist with OOS investigations, OOT investigations, and NCMR investigations, promoting thorough root cause analysis and sustainable corrective actions. - Complete required actions associated with identified corrective and preventive actions for the Quality department in a timely and effective manner. - Lead, mentor, and develop direct reports by setting clear objectives, providing ongoing coaching and feedback, and supporting professional growth and team success. Qualifications: - Bachelor's degree in Engineering, Biology, or Chemistry required. - Minimum of 10 years of experience in a cGMP, ISO 13485, or ISO 9001 Quality Management System environment required. - Minimum of 5-8 years of experience mentoring, developing, and supervising direct reports. - Excellent verbal and written communication skills with the ability to influence and build strong working relationships across functions. - Strong attention to detail and commitment to quality and compliance. - Collaborative team player who effectively partners across departments to achieve common goals and drive business success. - ASQ CQA and/or CQE certification preferred. - Experience with LEAN implementation strongly preferred. - Demonstrated ability to foster and sustain a Quality Culture across the organization through leadership, engagement, and accountability. - Demonstrated ability to mentor, train, coach, and develop quality professionals while building a high-performing and engaged team. Skills: maybe we can combine some of the qualifications that are skill-based: communication, influence, organizational, multitask, problem solving, negotiation, influence, facilitation, etc. But we can just put a Skills section listing those. Benefits: paid time off, health/dental/vision, retirement benefits, flexible spending accounts. Pay: estimated base salary range $180,000 - $230,000. Also mention variable cash programs (bonus or commission) and equity eligibility. We'll include that. Schedule: none, so omit. About the role: maybe a paragraph summarizing role: "We are seeking an experienced Quality Leader to join our Repligen Shrewsbury, MA facility. The Shrewsbury site includes both a manufacturing operation and distribution center, and this role will lead the Quality Operations and Incoming Quality Control teams that support both functions. The Director of Quality will oversee the site's ISO 9001 Quality Management System, build strong partnerships across the organization, and drive a culture of quality, continuous improvement, and accountability. This individual will mentor and develop a high-performing team while ensuring compliance, supporting business growth, and helping teams solve complex quality challenges. This role is expected to model our Leadership Behaviors—Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results—in all aspects of work." plus mission statement maybe. We must not repeat job title as heading. The job title is "Quality Leader" or "Director of Quality"? The posting says "We are seeking an experienced Quality Leader". We'll not repeat. Now produce HTML fragment. We need to ensure we don't include any extra text outside HTML. No markdown fences. Let's craft. Structure:
About the role
...
Responsibilities
- ... ...
Qualifications
- ... ...
Skills
- ... ...
Benefits
- Paid time off
- Health, dental, and vision insurance
- Retirement benefits
- Flexible spending accounts
Pay
The estimated base salary range for this role is $180,000 – $230,000. Employees are eligible to participate in variable cash programs (bonus or commission) and may receive equity as part of the compensation package.
We need to ensure we don't include any boilerplate like "All compensation and benefits information will be confirmed in writing at the time of offer." That's somewhat generic but maybe we can keep as it's substantive? It's a statement about confirmation; could be considered boilerplate but it's about compensation details. Might be okay to keep but it's not required. The instruction: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. That line is not exactly those; it's about compensation confirmation. Might be okay to keep but we can omit to keep concise. We'll keep only salary range and variable cash/equity. Now ensure we preserve all substantive info from responsibilities and qualifications. Let's list them precisely. Responsibilities list items (I'll condense but keep meaning): - Lead the Quality Operations and Incoming Quality Control teams supporting manufacturing and distribution. - Oversee the site's ISO 9001 Quality Management System. - Build strong partnerships across the organization. - Drive a culture of quality, continuous improvement, and accountability. - Mentor and develop a high‑performing team while ensuring compliance, supporting business growth, and helping teams solve complex quality challenges. - Model the Leadership Behaviors (Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, Accountability & Results) in all work. - Maintain compliance to ISO 9001 for all aspects of the QMS including internal and external auditing, nonconforming materials, CAPA, validation, complaint handling, change controls, and other product lifecycle management activities, while promoting a culture of quality, accountability, and continuous improvement. - Partner with cross‑functional stakeholders to drive continuous improvement initiatives and support achievement of shared business objectives. - Author and revise procedures and specifications with subject‑matter experts to ensure clarity, effectiveness, and regulatory compliance. - Ensure effective training and adoption of quality systems and procedures across the organization. - Foster a strong cross‑functional quality mindset and influence quality ownership at all levels. - Effectively communicate sound quality guidance based on regulatory requirements, customer expectations, and business needs, balancing strategic priorities with operational execution. - Apply quality knowledge strategically and operationally across projects in a matrix environment, demonstrating strong negotiation, influence, and facilitation skills. - Demonstrate strong organizational skills with the ability to multitask, prioritize, and drive results in a dynamic environment. - Adapt to changing business needs while maintaining focus on quality, compliance, and execution of key deliverables. - Exercise sound judgment, initiative, and problem‑solving skills to proactively identify and address quality‑related risks. - Serve as the Management Representative to the ISO 9001 registrar. - Develop, monitor, and compile quality metrics to support monthly KPI reporting and management review meetings, leveraging data for informed decision‑making and continuous improvement. - Facilitate operational excellence initiatives within Quality Assurance to improve efficiency, effectiveness, and overall quality performance. - Maintain internal and external audit schedules and ensure audit readiness across the organization. - Maintain a risk‑based strategy for overall quality compliance and continuous improvement in support of ISO 9001 requirements. - Collaborate closely with Global Supplier Quality to ensure timely investigation and remediation of supplier material issues, fostering strong internal and external partnerships. - Review and approve validation plans, deviations, failure investigations, and corrective action plans prior to implementation, ensuring appropriate risk assessment and compliance. - Assist with OOS, OOT, and NCMR investigations, promoting thorough root cause analysis and sustainable corrective actions. - Complete required actions associated with identified corrective and preventive actions for the Quality department in a timely and effective manner. - Lead, mentor, and develop direct reports by setting clear objectives, providing ongoing coaching and feedback, and supporting professional growth and team success. Qualifications list: - Bachelor's degree in Engineering, Biology, or Chemistry required. - Minimum of 10 years of experience in a cGMP, ISO 13485, or ISO 9001 Quality Management System environment required. - Minimum of 5‑8 years of experience mentoring, developing, and supervising direct reports. - Excellent verbal and written communication skills with the ability to influence and build strong working relationships across functions. - Strong attention to detail and commitment to quality and compliance. - Collaborative team player who effectively partners across departments to achieve common goals and drive business success. - ASQ CQA and/or CQE certification preferred. - Experience with LEAN implementation strongly preferred. - Demonstrated ability to foster and sustain a Quality Culture across the organization through leadership, engagement, and accountability. - Demonstrated ability to mentor, train, coach, and develop quality professionals while building a high‑performing and engaged team. Skills list: we can extract skill-based items from qualifications and responsibilities: communication, influence, relationship building, organizational, multitasking, prioritization, problem solving