Senior Quality Systems Specialist
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.
We need to parse the posting.
Content:
- 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 primary responsibilities of the Senior Quality Systems Specialist involve Systems oversight & customer focus within our all-Quality Management Systems, relaying trends to Senior Management and implementing improvements on a continuous and pro-active basis. You will coordinate necessary activities for ensuring the timely closure of internal/external quality issues/projects and to coordinate/drive continuous improvement initiatives including mentoring to the business with respect to the relevant quality tools. Central to this role will be the need to liaise with companywide departments to ensure internal system compliance and customer specifications are achieved and to coach and drive a culture of compliance and continuous improvement. Ensuring site compliance with corporate, regulatory and customer quality standards will be at the forefront of the responsibilities. This role reports directly to the Quality Systems Manager."
- Essential Duties And Responsibilities: a long list of bullet-like sentences (each separated by period). We need to turn them into
- items.
- Education: "Bachelor's Degree in Engineering, Quality, Science or equivalent experience required"
- Work Experience: "Minimum of 5 years’ experience of working in a high-volume manufacturing environment ideally in the pharmaceutical industry.Working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 QMSR/21 CFR Part 210/211 is essential."
- Preferred Knowledge, Skills And Abilities: list of bullet-like sentences.
- Additional Requirements: list of bullet-like sentences.
- Travel Requirements: "5%: Up to 13 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.
Possible sections: About the role (maybe combine description and company overview), Responsibilities (Essential Duties), Requirements (Education + Work Experience), Qualifications (Preferred Knowledge, Skills And Abilities), Skills (maybe Additional Requirements?), Benefits? Not mentioned except "Supported by benefit programs" in company overview but not specific benefits. No explicit benefits listed. So we should not create Benefits section unless specific benefits are stated. The phrase "Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families." is generic but not specific benefits; it's more about company culture. Probably we should not create a Benefits section because no concrete benefits like health insurance, 401k, etc. The instruction: never create Pay/Schedule/Benefits sections unless the posting actually states them. So we should omit Benefits, Pay, Schedule.
Travel Requirements: we have specific travel % and days. That could be a section "Travel". But the allowed headings list includes Schedule, Benefits, Pay. Travel is not in the examples but we could still use a heading if we think it's appropriate? The instruction says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It says e.g., not exclusive list. So we can add other headings like Travel, Physical Requirements if needed. However we should prefer few substantive sections over many thin ones. Travel is a single sentence; maybe we could incorporate into a "Requirements" or "Additional Information" section. But we have to preserve all substantive info. Could create a section "Travel Requirements" with that sentence. Similarly Physical Requirements could be a section.
But we need to avoid filler. Travel and Physical Requirements are specific.
We also have "No relocation is provided for this opportunity." That's a detail about relocation; could be included in description or a note.
We need to remove EEO boilerplate etc.
Let's structure:
About the role
This is an onsite position requiring the team member to be onsite 5 days a week. No relocation is provided for this opportunity.
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 primary responsibilities of the Senior Quality Systems Specialist involve Systems oversight & customer focus within our all-Quality Management Systems, relaying trends to Senior Management and implementing improvements on a continuous and pro-active basis. You will coordinate necessary activities for ensuring the timely closure of internal/external quality issues/projects and to coordinate/drive continuous improvement initiatives including mentoring to the business with respect to the relevant quality tools. Central to this role will be the need to liaise with companywide departments to ensure internal system compliance and customer specifications are achieved and to coach and drive a culture of compliance and continuous improvement. Ensuring site compliance with corporate, regulatory and customer quality standards will be at the forefront of the responsibilities. This role reports directly to the Quality Systems Manager.
Responsibilities
- Support the harmonization and deployment of site quality systems into standardized Operating Unit-level processes, ensuring effective implementation, consistency, and the sharing of best practices across the network.
- Provide training and guidance on Quality Management System (QMS) processes, including Change Management, CAPA, Deviation Management, Document Control, and associated compliance requirements.
- Manage key quality system processes at site level, including Global Alerts, Document Control System sub-administration, CAPA governance, and Change Management oversight.
- Lead and support investigations related to Quality System issues, ensuring robust root cause analysis and the implementation of effective containment, corrective, and preventive actions.
- Identify, monitor, trend, and escalate systemic quality risks, adverse trends, significant quality events, and compliance concerns to appropriate stakeholders and senior leadership.
- Monitor quality system performance through metrics, trend analysis, and key reports, and recommend actions to improve compliance, effectiveness, and overall system performance.
- Support regulatory submissions, responses to Regulatory Bodies and Competent Authorities, and inspection readiness activities for internal audits, external audits, Notified Bodies, FDA, and other regulatory authorities.
- Support risk management activities, including risk analysis and hazard analysis associated with complaints, post-market surveillance information, and other quality system inputs, as applicable.
- Coordinate post-audit and post-inspection follow-up activities, including action tracking, reporting, closure, and verification of effectiveness to ensure findings are satisfactorily addressed.
- Support Management Review activities through scheduling, data collection, reporting, and presentation of key quality system information and performance trends.
- Participate in the review, development, implementation, and continuous improvement of procedures, processes, and systems in line with regulatory requirements and industry best practices.
- Partner with cross-functional teams and site leadership to embed quality system compliance, promote data integrity, and foster a culture of compliance, accountability, and continuous improvement.
- Perform additional duties as assigned by the direct supervisor.
Education
Bachelor's Degree in Engineering, Quality, Science or equivalent experience required
Work Experience
Minimum of 5 years’ experience of working in a high-volume manufacturing environment ideally in the pharmaceutical industry. Working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 QMSR/21 CFR Part 210/211 is essential.
Preferred Knowledge, Skills and Abilities
- Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
- Able to comply with the company’s safety policy at all times.
- Able to comply with the company’s quality policy at all times.
- Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 QMSR, 21 CFR Part 4, 21 CFR Part 210/211, EU GMP Volume 4 is preferred.
- A background in drug handling would be considered an advantage.
Additional Requirements
- Thrive in a fast-paced environment where teamwork and collaboration drive success.
- Bring a positive, can-do attitude every day as we build and grow together.
- Contribute to ramping up a state-of-the-art manufacturing facility from the ground up.
- Embrace change and innovation as we launch new operations at record speed.
- Work hard, stay flexible, and support your teammates to achieve shared goals.
- Take pride in producing high-quality products that improve patient lives worldwide.
- Live West’s core values of integrity, teamwork, and accountability in everything you do.
- Be part of a culture that celebrates learning, problem
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. We need to parse the posting. Content: - 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 primary responsibilities of the Senior Quality Systems Specialist involve Systems oversight & customer focus within our all-Quality Management Systems, relaying trends to Senior Management and implementing improvements on a continuous and pro-active basis. You will coordinate necessary activities for ensuring the timely closure of internal/external quality issues/projects and to coordinate/drive continuous improvement initiatives including mentoring to the business with respect to the relevant quality tools. Central to this role will be the need to liaise with companywide departments to ensure internal system compliance and customer specifications are achieved and to coach and drive a culture of compliance and continuous improvement. Ensuring site compliance with corporate, regulatory and customer quality standards will be at the forefront of the responsibilities. This role reports directly to the Quality Systems Manager." - Essential Duties And Responsibilities: a long list of bullet-like sentences (each separated by period). We need to turn them into
- items.
- Education: "Bachelor's Degree in Engineering, Quality, Science or equivalent experience required"
- Work Experience: "Minimum of 5 years’ experience of working in a high-volume manufacturing environment ideally in the pharmaceutical industry.Working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 QMSR/21 CFR Part 210/211 is essential."
- Preferred Knowledge, Skills And Abilities: list of bullet-like sentences.
- Additional Requirements: list of bullet-like sentences.
- Travel Requirements: "5%: Up to 13 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.
Possible sections: About the role (maybe combine description and company overview), Responsibilities (Essential Duties), Requirements (Education + Work Experience), Qualifications (Preferred Knowledge, Skills And Abilities), Skills (maybe Additional Requirements?), Benefits? Not mentioned except "Supported by benefit programs" in company overview but not specific benefits. No explicit benefits listed. So we should not create Benefits section unless specific benefits are stated. The phrase "Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families." is generic but not specific benefits; it's more about company culture. Probably we should not create a Benefits section because no concrete benefits like health insurance, 401k, etc. The instruction: never create Pay/Schedule/Benefits sections unless the posting actually states them. So we should omit Benefits, Pay, Schedule.
Travel Requirements: we have specific travel % and days. That could be a section "Travel". But the allowed headings list includes Schedule, Benefits, Pay. Travel is not in the examples but we could still use a heading if we think it's appropriate? The instruction says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It says e.g., not exclusive list. So we can add other headings like Travel, Physical Requirements if needed. However we should prefer few substantive sections over many thin ones. Travel is a single sentence; maybe we could incorporate into a "Requirements" or "Additional Information" section. But we have to preserve all substantive info. Could create a section "Travel Requirements" with that sentence. Similarly Physical Requirements could be a section. But we need to avoid filler. Travel and Physical Requirements are specific. We also have "No relocation is provided for this opportunity." That's a detail about relocation; could be included in description or a note. We need to remove EEO boilerplate etc. Let's structure:
About the role
This is an onsite position requiring the team member to be onsite 5 days a week. No relocation is provided for this opportunity.
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 primary responsibilities of the Senior Quality Systems Specialist involve Systems oversight & customer focus within our all-Quality Management Systems, relaying trends to Senior Management and implementing improvements on a continuous and pro-active basis. You will coordinate necessary activities for ensuring the timely closure of internal/external quality issues/projects and to coordinate/drive continuous improvement initiatives including mentoring to the business with respect to the relevant quality tools. Central to this role will be the need to liaise with companywide departments to ensure internal system compliance and customer specifications are achieved and to coach and drive a culture of compliance and continuous improvement. Ensuring site compliance with corporate, regulatory and customer quality standards will be at the forefront of the responsibilities. This role reports directly to the Quality Systems Manager.
Responsibilities
- Support the harmonization and deployment of site quality systems into standardized Operating Unit-level processes, ensuring effective implementation, consistency, and the sharing of best practices across the network.
- Provide training and guidance on Quality Management System (QMS) processes, including Change Management, CAPA, Deviation Management, Document Control, and associated compliance requirements.
- Manage key quality system processes at site level, including Global Alerts, Document Control System sub-administration, CAPA governance, and Change Management oversight.
- Lead and support investigations related to Quality System issues, ensuring robust root cause analysis and the implementation of effective containment, corrective, and preventive actions.
- Identify, monitor, trend, and escalate systemic quality risks, adverse trends, significant quality events, and compliance concerns to appropriate stakeholders and senior leadership.
- Monitor quality system performance through metrics, trend analysis, and key reports, and recommend actions to improve compliance, effectiveness, and overall system performance.
- Support regulatory submissions, responses to Regulatory Bodies and Competent Authorities, and inspection readiness activities for internal audits, external audits, Notified Bodies, FDA, and other regulatory authorities.
- Support risk management activities, including risk analysis and hazard analysis associated with complaints, post-market surveillance information, and other quality system inputs, as applicable.
- Coordinate post-audit and post-inspection follow-up activities, including action tracking, reporting, closure, and verification of effectiveness to ensure findings are satisfactorily addressed.
- Support Management Review activities through scheduling, data collection, reporting, and presentation of key quality system information and performance trends.
- Participate in the review, development, implementation, and continuous improvement of procedures, processes, and systems in line with regulatory requirements and industry best practices.
- Partner with cross-functional teams and site leadership to embed quality system compliance, promote data integrity, and foster a culture of compliance, accountability, and continuous improvement.
- Perform additional duties as assigned by the direct supervisor.
Education
Bachelor's Degree in Engineering, Quality, Science or equivalent experience required
Work Experience
Minimum of 5 years’ experience of working in a high-volume manufacturing environment ideally in the pharmaceutical industry. Working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 QMSR/21 CFR Part 210/211 is essential.
Preferred Knowledge, Skills and Abilities
- Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
- Able to comply with the company’s safety policy at all times.
- Able to comply with the company’s quality policy at all times.
- Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 QMSR, 21 CFR Part 4, 21 CFR Part 210/211, EU GMP Volume 4 is preferred.
- A background in drug handling would be considered an advantage.
Additional Requirements
- Thrive in a fast-paced environment where teamwork and collaboration drive success.
- Bring a positive, can-do attitude every day as we build and grow together.
- Contribute to ramping up a state-of-the-art manufacturing facility from the ground up.
- Embrace change and innovation as we launch new operations at record speed.
- Work hard, stay flexible, and support your teammates to achieve shared goals.
- Take pride in producing high-quality products that improve patient lives worldwide.
- Live West’s core values of integrity, teamwork, and accountability in everything you do.
- Be part of a culture that celebrates learning, problem