Manager, QA Evening 12 hour Shift (6:00pm-6:00am)
BioSpace, New Albany, OH, United States
Our mission is to serve patients living with serious illnesses. Amgen’s Ohio site seeks a Manager, Plant Quality to lead quality assurance and drive continuous improvement across manufacturing and quality systems.
What You’ll Do
As a QA Manager, you will lead and elevate quality performance, provide strategic and operational oversight across manufacturing and quality systems, and shape the quality culture.
Responsibilities
Lead, coach, and develop quality staff across assigned areas and shifts.
Provide QA oversight of manufacturing and packaging activities to ensure compliance with cGMP, GDP, and global regulatory requirements.
Ensure facilities, equipment, processes, materials, and products meet all applicable quality and compliance standards.
Review, approve, and oversee key quality systems including deviations, CAPAs, change controls, validation documentation, procedures, and batch records.
Drive investigations and resolution of deviations to ensure timely, thorough, compliant outcomes.
Ensure production records and test results are accurate, complete, and inspection‑ready.
Champion and lead continuous improvement initiatives to strengthen quality systems and operational performance.
Partner cross‑functionally with Manufacturing, QC, Engineering, Supply Chain, and other stakeholders.
Assess and manage quality risks, escalating critical issues to senior leadership as needed.
Represent QA during internal and external audits and regulatory inspections.
Support audit readiness and participate in inspection management activities.
Ensure document control excellence, including ownership and timely periodic review of controlled documents.
Foster a culture of quality, accountability, and compliance across all teams.
Basic Qualifications
Doctorate degree.
Or Masters degree and 3 years of quality experience.
Or Bachelors degree and 5 years of quality experience.
Or Associates degree and 10 years quality experience.
Or High school diploma / GED and 12 years of quality experience.
Experience directly managing people and/or leading teams, projects, or programs.
Preferred Qualifications
Bachelors degree in Life Sciences, Engineering, or a related field (advanced degree a plus).
3+ years of experience in Quality Assurance within a GMP‑regulated environment (biotech/pharma preferred).
Prior leadership or people‑management experience strongly preferred.
Deep knowledge of cGMP, GDP, and regulatory expectations.
Proven experience with quality systems (deviations, CAPA, change control, validation).
Strong ability to lead in a shift‑based operation, with flexibility for evenings, nights, weekends, or holidays.
Excellent communication, decision‑making, and problem‑solving skills.
A proactive, collaborative leader who can influence and inspire across functions.
Benefits
A comprehensive employee benefits package, including a retirement and savings plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan.
Stock‑based long‑term incentives.
Award‑winning time‑off plans.
Flexible work models where possible.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
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What You’ll Do
As a QA Manager, you will lead and elevate quality performance, provide strategic and operational oversight across manufacturing and quality systems, and shape the quality culture.
Responsibilities
Lead, coach, and develop quality staff across assigned areas and shifts.
Provide QA oversight of manufacturing and packaging activities to ensure compliance with cGMP, GDP, and global regulatory requirements.
Ensure facilities, equipment, processes, materials, and products meet all applicable quality and compliance standards.
Review, approve, and oversee key quality systems including deviations, CAPAs, change controls, validation documentation, procedures, and batch records.
Drive investigations and resolution of deviations to ensure timely, thorough, compliant outcomes.
Ensure production records and test results are accurate, complete, and inspection‑ready.
Champion and lead continuous improvement initiatives to strengthen quality systems and operational performance.
Partner cross‑functionally with Manufacturing, QC, Engineering, Supply Chain, and other stakeholders.
Assess and manage quality risks, escalating critical issues to senior leadership as needed.
Represent QA during internal and external audits and regulatory inspections.
Support audit readiness and participate in inspection management activities.
Ensure document control excellence, including ownership and timely periodic review of controlled documents.
Foster a culture of quality, accountability, and compliance across all teams.
Basic Qualifications
Doctorate degree.
Or Masters degree and 3 years of quality experience.
Or Bachelors degree and 5 years of quality experience.
Or Associates degree and 10 years quality experience.
Or High school diploma / GED and 12 years of quality experience.
Experience directly managing people and/or leading teams, projects, or programs.
Preferred Qualifications
Bachelors degree in Life Sciences, Engineering, or a related field (advanced degree a plus).
3+ years of experience in Quality Assurance within a GMP‑regulated environment (biotech/pharma preferred).
Prior leadership or people‑management experience strongly preferred.
Deep knowledge of cGMP, GDP, and regulatory expectations.
Proven experience with quality systems (deviations, CAPA, change control, validation).
Strong ability to lead in a shift‑based operation, with flexibility for evenings, nights, weekends, or holidays.
Excellent communication, decision‑making, and problem‑solving skills.
A proactive, collaborative leader who can influence and inspire across functions.
Benefits
A comprehensive employee benefits package, including a retirement and savings plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan.
Stock‑based long‑term incentives.
Award‑winning time‑off plans.
Flexible work models where possible.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
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