Quality Systems Manager
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Use - for any list of duties/requirements/benefits, and
for prose. Do NOT repeat the job title as a heading. Do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones. Output ONLY the HTML fragment — no /, no markdown code fences.
We need to parse the job posting.
Key parts:
- Description: "This is an onsite position requiring the team member to be onsite 5 days a week. No relocation is provided for this opportunity."
- Then a paragraph about West: "At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts."
- Job Summary: "The Quality Systems Manager leads the governance, compliance and continual improvement of the Quality Management System (QMS) for West, Indiana. The role ensures the QMS remains effective, inspection-ready and compliant with applicable drug product, medical device, combination product, customer and West requirements. The position leads the Quality Systems team and is responsible for Quality Systems, regulatory readiness, supplier quality governance, risk management and continuous improvement. The Quality Systems Manager reports into the Site Quality Director."
- Essential Duties And Responsibilities: a long list of bullet-like sentences each starting with a verb. We need to turn them into
- .
- Education: "Bachelor’s Degree in a technical discipline to include; Science, Quality or Engineering or equivalent experience"
- Work Experience: "Minimum of 8 years of Quality/ Regulatory management in process-based manufacturing for the medical device and/or pharmaceutical industry. Proven experience in Medical Device and Pharmaceutical Packaging and Combination Products regulations e.g., EU GMP, 21 CFR Part 210/211 and Part 4, ISO13485, 21CFR Part 820 QMSR. Experience developing and maintaining a QMS supporting EU and US markets and hosting customer, corporate and regulatory audits or inspections. Proven general leadership and quality management experience which includes quality execution, analysis and deadline driven. Excellent computer skills, experience with MS Office, ERP systems, Statistical software etc. Demonstrated experience leading people, Quality Systems, compliance programs or cross-functional quality improvement initiative."
- Preferred Knowledge, Skills And Abilities: list of items.
- Additional Requirements: list of bullet-like statements.
- Travel Requirements: "10%: Up to 26 business days per year"
- Physical Requirements: "Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time."
- Then EEO boilerplate etc to remove.
We need to decide sections.
We have:
- About the role? Could combine description and job summary? The instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We can choose sections that have substantive content.
We have:
- About the role: maybe the description about onsite and no relocation? Or the West mission paragraph? Could be "About the role" includes the onsite requirement and maybe the West description. But we need to preserve all substantive info.
Better to have sections:
- About the role (or About West) containing the description paragraph about West and the onsite requirement.
- Responsibilities: the Essential Duties And Responsibilities list.
- Qualifications: Education + Work Experience (maybe combine as Qualifications). Or separate Education and Experience? The instruction allows Qualifications heading.
- Skills: Preferred Knowledge, Skills And Abilities.
- Additional Requirements: maybe under Requirements? Could be "Additional Requirements" but not in the list of allowed headings. The allowed headings list includes Requirements (maybe generic). Could use "Requirements" for the Additional Requirements bullet list.
- Travel Requirements: maybe under Schedule? Actually Travel is separate; but we have no heading for Travel. Could include under "Schedule" if we treat travel as schedule? But schedule usually refers to work schedule (onsite 5 days a week). Travel 10% could be under "Travel" but not allowed. Could we add a section "Travel"? The instruction says use headings e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. It says "e.g." meaning those are examples, not exclusive? It says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Likely they expect us to use those headings only. So we should not create other headings like Travel or Physical Requirements. However we need to preserve all substantive information. Where to put travel and physical requirements? Could fold them into a short
under maybe "Requirements" or "Additional Requirements" but we cannot create a heading not in list. Could we put them under "Requirements" as a paragraph? The instruction: "Do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it." Travel and physical requirements are not minor metadata; they are substantive. But we have no heading for them. Perhaps we can include them under "Requirements" as a paragraph (since requirements can include travel and physical). Or we could create a section "Schedule" for the onsite 5 days a week, and maybe travel under Schedule? Not ideal.
Better approach: Use headings: About the role, Responsibilities, Qualifications, Skills, Requirements (for travel/physical), Benefits? No benefits mentioned. Pay? Not mentioned. Schedule? Could include onsite requirement.
But we need to preserve all substantive info. Let's see what we have:
- Onsite 5 days a week, no relocation: could be under Schedule (onsite) and maybe also under Requirements (no relocation). But schedule heading is for work schedule.
- Travel Requirements: 10% up to 26 business days per year: could be under Schedule as well (travel schedule). Or under Requirements.
- Physical Requirements: Sedentary etc: could be under Requirements.
Thus we can have sections:
- About the role (West mission + maybe onsite? but onsite is schedule)
- Responsibilities (Essential Duties)
- Qualifications (Education + Work Experience)
- Skills (Preferred Knowledge, Skills And Abilities)
- Requirements (Travel Requirements, Physical Requirements, maybe also no relocation? but no relocation is minor metadata? Could be folded into a short p.)
- Benefits? Not mentioned.
- Pay? Not mentioned.
- Schedule? Could be separate for onsite 5 days a week. But we already used Requirements for travel/physical; we could still have Schedule for onsite.
But we need to avoid thin sections. Perhaps combine onsite and travel under Schedule? Schedule could include both regular schedule and travel. Physical requirements maybe under Requirements.
Let's decide:
Sections:
- About the role: West mission paragraph (the long paragraph about West). Also maybe include the statement "This is an onsite position requiring the team member to be onsite 5 days a week. No relocation is provided for this opportunity." Could be part of About the role or Schedule.
- Responsibilities: Essential Duties And Responsibilities list.
- Qualifications: Education and Work Experience.
- Skills: Preferred Knowledge, Skills And Abilities.
- Requirements: Travel Requirements and Physical Requirements (maybe also no relocation as a short p).
- Benefits: none -> omit.
- Pay: none -> omit.
- Schedule: maybe we already used schedule? Actually we haven't used Schedule yet. Could put onsite 5 days a week under Schedule. But we already put travel under Requirements; maybe better to put travel under Schedule as well. Let's think.
We have two schedule-related items: regular onsite schedule (5 days/week) and travel (10% up to 26 business days). Both could be under Schedule heading. Physical requirements could be under Requirements.
Thus:
- About the role: West mission paragraph.
- Responsibilities: list.
- Qualifications: Education + Work Experience.
- Skills: Preferred Knowledge, Skills And Abilities.
- Requirements: Physical Requirements (maybe also no relocation as short p).
- Schedule: Onsite 5 days a week, Travel 10% up to 26 business days per year.
We need to ensure we don't create sections with filler. All have content.
Now we need to format.
Use
for each heading.
Inside each section, use
for prose,
- for lists.
We need to preserve all substantive information; do not invent or summarize away detail.
Let's extract exact text.
About the role paragraph: The West mission paragraph is:
"At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts."
We also have the onsite statement: "This is an onsite position requiring the team member to be onsite 5 days a week. No relocation is provided for this opportunity."
We could include that in About the role as a short p after the mission paragraph, or under Schedule. Let's put it under Schedule as part of schedule details.
Thus About the role will just be the West mission paragraph.
Now Responsibilities: list of duties. Need to capture each bullet exactly as in the posting.
The Essential Duties And Responsibilities section includes sentences each starting with a verb. Let's copy them:
- Lead, develop and coach the Quality Systems team through effective performance management, succession planning and capability development.
- Own the site QMS, ensuring effective governance, compliance, process ownership, performance monitoring and continual improvement.
- Oversee deviations and non-conform
for prose. Do NOT repeat the job title as a heading. Do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones. Output ONLY the HTML fragment — no /, no markdown code fences. We need to parse the job posting. Key parts: - Description: "This is an onsite position requiring the team member to be onsite 5 days a week. No relocation is provided for this opportunity." - Then a paragraph about West: "At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts." - Job Summary: "The Quality Systems Manager leads the governance, compliance and continual improvement of the Quality Management System (QMS) for West, Indiana. The role ensures the QMS remains effective, inspection-ready and compliant with applicable drug product, medical device, combination product, customer and West requirements. The position leads the Quality Systems team and is responsible for Quality Systems, regulatory readiness, supplier quality governance, risk management and continuous improvement. The Quality Systems Manager reports into the Site Quality Director." - Essential Duties And Responsibilities: a long list of bullet-like sentences each starting with a verb. We need to turn them into
- .
- Education: "Bachelor’s Degree in a technical discipline to include; Science, Quality or Engineering or equivalent experience"
- Work Experience: "Minimum of 8 years of Quality/ Regulatory management in process-based manufacturing for the medical device and/or pharmaceutical industry. Proven experience in Medical Device and Pharmaceutical Packaging and Combination Products regulations e.g., EU GMP, 21 CFR Part 210/211 and Part 4, ISO13485, 21CFR Part 820 QMSR. Experience developing and maintaining a QMS supporting EU and US markets and hosting customer, corporate and regulatory audits or inspections. Proven general leadership and quality management experience which includes quality execution, analysis and deadline driven. Excellent computer skills, experience with MS Office, ERP systems, Statistical software etc. Demonstrated experience leading people, Quality Systems, compliance programs or cross-functional quality improvement initiative."
- Preferred Knowledge, Skills And Abilities: list of items.
- Additional Requirements: list of bullet-like statements.
- Travel Requirements: "10%: Up to 26 business days per year"
- Physical Requirements: "Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time."
- Then EEO boilerplate etc to remove.
We need to decide sections.
We have:
- About the role? Could combine description and job summary? The instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We can choose sections that have substantive content.
We have:
- About the role: maybe the description about onsite and no relocation? Or the West mission paragraph? Could be "About the role" includes the onsite requirement and maybe the West description. But we need to preserve all substantive info.
Better to have sections:
- About the role (or About West) containing the description paragraph about West and the onsite requirement.
- Responsibilities: the Essential Duties And Responsibilities list.
- Qualifications: Education + Work Experience (maybe combine as Qualifications). Or separate Education and Experience? The instruction allows Qualifications heading.
- Skills: Preferred Knowledge, Skills And Abilities.
- Additional Requirements: maybe under Requirements? Could be "Additional Requirements" but not in the list of allowed headings. The allowed headings list includes Requirements (maybe generic). Could use "Requirements" for the Additional Requirements bullet list.
- Travel Requirements: maybe under Schedule? Actually Travel is separate; but we have no heading for Travel. Could include under "Schedule" if we treat travel as schedule? But schedule usually refers to work schedule (onsite 5 days a week). Travel 10% could be under "Travel" but not allowed. Could we add a section "Travel"? The instruction says use headings e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. It says "e.g." meaning those are examples, not exclusive? It says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Likely they expect us to use those headings only. So we should not create other headings like Travel or Physical Requirements. However we need to preserve all substantive information. Where to put travel and physical requirements? Could fold them into a short
under maybe "Requirements" or "Additional Requirements" but we cannot create a heading not in list. Could we put them under "Requirements" as a paragraph? The instruction: "Do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it." Travel and physical requirements are not minor metadata; they are substantive. But we have no heading for them. Perhaps we can include them under "Requirements" as a paragraph (since requirements can include travel and physical). Or we could create a section "Schedule" for the onsite 5 days a week, and maybe travel under Schedule? Not ideal. Better approach: Use headings: About the role, Responsibilities, Qualifications, Skills, Requirements (for travel/physical), Benefits? No benefits mentioned. Pay? Not mentioned. Schedule? Could include onsite requirement. But we need to preserve all substantive info. Let's see what we have: - Onsite 5 days a week, no relocation: could be under Schedule (onsite) and maybe also under Requirements (no relocation). But schedule heading is for work schedule. - Travel Requirements: 10% up to 26 business days per year: could be under Schedule as well (travel schedule). Or under Requirements. - Physical Requirements: Sedentary etc: could be under Requirements. Thus we can have sections: - About the role (West mission + maybe onsite? but onsite is schedule) - Responsibilities (Essential Duties) - Qualifications (Education + Work Experience) - Skills (Preferred Knowledge, Skills And Abilities) - Requirements (Travel Requirements, Physical Requirements, maybe also no relocation? but no relocation is minor metadata? Could be folded into a short p.) - Benefits? Not mentioned. - Pay? Not mentioned. - Schedule? Could be separate for onsite 5 days a week. But we already used Requirements for travel/physical; we could still have Schedule for onsite. But we need to avoid thin sections. Perhaps combine onsite and travel under Schedule? Schedule could include both regular schedule and travel. Physical requirements maybe under Requirements. Let's decide: Sections: - About the role: West mission paragraph (the long paragraph about West). Also maybe include the statement "This is an onsite position requiring the team member to be onsite 5 days a week. No relocation is provided for this opportunity." Could be part of About the role or Schedule. - Responsibilities: Essential Duties And Responsibilities list. - Qualifications: Education and Work Experience. - Skills: Preferred Knowledge, Skills And Abilities. - Requirements: Travel Requirements and Physical Requirements (maybe also no relocation as a short p). - Benefits: none -> omit. - Pay: none -> omit. - Schedule: maybe we already used schedule? Actually we haven't used Schedule yet. Could put onsite 5 days a week under Schedule. But we already put travel under Requirements; maybe better to put travel under Schedule as well. Let's think. We have two schedule-related items: regular onsite schedule (5 days/week) and travel (10% up to 26 business days). Both could be under Schedule heading. Physical requirements could be under Requirements. Thus: - About the role: West mission paragraph. - Responsibilities: list. - Qualifications: Education + Work Experience. - Skills: Preferred Knowledge, Skills And Abilities. - Requirements: Physical Requirements (maybe also no relocation as short p). - Schedule: Onsite 5 days a week, Travel 10% up to 26 business days per year. We need to ensure we don't create sections with filler. All have content. Now we need to format. Use
for each heading. Inside each section, use
for prose,
- for lists. We need to preserve all substantive information; do not invent or summarize away detail. Let's extract exact text. About the role paragraph: The West mission paragraph is: "At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts." We also have the onsite statement: "This is an onsite position requiring the team member to be onsite 5 days a week. No relocation is provided for this opportunity." We could include that in About the role as a short p after the mission paragraph, or under Schedule. Let's put it under Schedule as part of schedule details. Thus About the role will just be the West mission paragraph. Now Responsibilities: list of duties. Need to capture each bullet exactly as in the posting. The Essential Duties And Responsibilities section includes sentences each starting with a verb. Let's copy them: - Lead, develop and coach the Quality Systems team through effective performance management, succession planning and capability development. - Own the site QMS, ensuring effective governance, compliance, process ownership, performance monitoring and continual improvement. - Oversee deviations and non-conform