Senior Specialist Investigations & Regulatory Inspections
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you're part of something bigger, it's because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
What you will do
Let's do this. Let's change the world. In this vital role, you will be a key member of the team that investigates major deviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between the GMP manufacturing teams and stakeholder groups including, Process Development, Facilities & Engineering, Automation, EHS S, and Quality. This position is responsible for ensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process.
Responsibilities include:
- Manage the site's most complex major deviation investigations, including assembling investigation teams, leading advanced root cause analysis, development of CAPAs, and compliant documentation of findings.
- Partner with Manufacturing and site inspection readiness teams to prepare for regulatory inspections and internal audits, ensuring manufacturing investigations, records, and supporting documentation are inspection-ready.
- Coordinate inspection strategy, response development, and war room activities during regulatory inspections.
- Author, review, and approve inspection responses, commitments, and remediation plans.
- Review, author, and provide consultation on complex deviation investigations to ensure technical rigor, regulatory compliance, and inspection readiness.
- Develop investigation storyboards, inspection narratives, and supporting materials that clearly communicate event history, impact assessments, root cause determinations, corrective actions, and product impact decisions.
- Provide an independent audit-readiness perspective on investigations and quality records, identifying potential gaps, weaknesses, or areas requiring additional technical justification prior to closure.
- Partner with Manufacturing teams to prepare subject matter experts for regulatory inspections, internal audits, and quality reviews through coaching, mock interviews, and inspection readiness activities.
- Evaluate audit observations, inspection feedback, and investigation trends to identify opportunities for strengthening investigation practices, quality systems, and inspection readiness.
- Drive continuous improvements to investigation processes, quality systems, and inspection readiness programs.
- Provide expert consultation and coaching on advanced root cause analysis methodologies.
- Clearly communicate investigation progress, risks, and outcomes to impacted areas and senior leadership.
- Coordinate and effectively lead cross-functional teams through high-impact investigations and complete milestones on schedule.
- Present complex technical topics to leadership, auditors, and health authority inspectors.
- Partner with Quality, Manufacturing, Engineering, Process Development, Automation, and corporate functions to strengthen quality culture and compliance.
- Develop and maintain metrics to assess investigation effectiveness, CAPA effectiveness, and inspection readiness.
- Mentor investigators and cross-functional teams on investigation excellence, technical writing, and regulatory expectations.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The collaborative investigator we seek has a biologics Drug Substance manufacturing and investigations background with strong cross-functional project management, regulatory presentation experience, and communication skills as well as the below qualifications.
Basic Qualifications:
Doctorate degree & 2 year of directly related experience
Or
Master's degree & 4 years of directly related experience
Or
Bachelor's degree or & 6 years of directly related experience
Or
Associate's degree & 10 years of directly related experience
Or
High school diploma / GED & 12 years of directly related experience
Preferred Qualifications:
- 7 + years related work experience (manufacturing, microbiology, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
- Demonstrated expertise leading complex investigations and assessing investigation quality, technical rigor, and regulatory compliance.
- Extensive experience with compliance, root cause analysis methodologies, quality risk management, CAPA effectiveness, and quality systems.
- Degree in Science or Engineering.
- Deep knowledge of FDA, EMA, and global GMP regulations, inspection expectations, and industry best practices related to investigation management and quality systems.
- Demonstrated success serving as a technical SME during regulatory inspections, internal audits, and inspection readiness activities.
- Experience using Veeva QMS for deviation investigations and CAPAs.
- Strong project and program management skills.
- Experience influencing senior leadership and driving site-wide quality initiatives.
- Demonstrated ability to mentor and develop investigators and technical professionals.
- Excellent written and verbal communication skills.
- Experience reviewing, authoring, or coaching complex deviation investigations to ensure technical rigor, regulatory compliance, and inspection readiness.
- Experience developing investigation narratives, storyboards, or technical presentations to effectively communicate quality events during audits and regulatory inspections.
- Experience preparing manufacturing personnel and subject matter experts for regulatory inspections, internal audits, or management reviews.
- Strong understanding of manufacturing operations, deviation management, CAPA systems, and inspection readiness principles.
- Ability to work effectively in a matrix environment and build strong cross-functional relationships.
Thrive
What you can expect of us
In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
- 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 and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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. Please contact us to request accommodation.
Salary Range
137,263.10USD -185,708.90 USD
Senior Specialist Investigations & Regulatory Inspections
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you're part of something bigger, it's because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
What you will do
Let's do this. Let's change the world. In this vital role, you will be a key member of the team that investigates major deviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between the GMP manufacturing teams and stakeholder groups including, Process Development, Facilities & Engineering, Automation, EHS S, and Quality. This position is responsible for ensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process.
Responsibilities include:
- Manage the site's most complex major deviation investigations, including assembling investigation teams, leading advanced root cause analysis, development of CAPAs, and compliant documentation of findings.
- Partner with Manufacturing and site inspection readiness teams to prepare for regulatory inspections and internal audits, ensuring manufacturing investigations, records, and supporting documentation are inspection-ready.
- Coordinate inspection strategy, response development, and war room activities during regulatory inspections.
- Author, review, and approve inspection responses, commitments, and remediation plans.
- Review, author, and provide consultation on complex deviation investigations to ensure technical rigor, regulatory compliance, and inspection readiness.
- Develop investigation storyboards, inspection narratives, and supporting materials that clearly communicate event history, impact assessments, root cause determinations, corrective actions, and product impact decisions.
- Provide an independent audit-readiness perspective on investigations and quality records, identifying potential gaps, weaknesses, or areas requiring additional technical justification prior to closure.
- Partner with Manufacturing teams to prepare subject matter experts for regulatory inspections, internal audits, and quality reviews through coaching, mock interviews, and inspection readiness activities.
- Evaluate audit observations, inspection feedback, and investigation trends to identify opportunities for strengthening investigation practices, quality systems, and inspection readiness.
- Drive continuous improvements to investigation processes, quality systems, and inspection readiness programs.
- Provide expert consultation and coaching on advanced root cause analysis methodologies.
- Clearly communicate investigation progress, risks, and outcomes to impacted areas and senior leadership.
- Coordinate and effectively lead cross-functional teams through high-impact investigations and complete milestones on schedule.
- Present complex technical topics to leadership, auditors, and health authority inspectors.
- Partner with Quality, Manufacturing, Engineering, Process Development, Automation, and corporate functions to strengthen quality culture and compliance.
- Develop and maintain metrics to assess investigation effectiveness, CAPA effectiveness, and inspection readiness.
- Mentor investigators and cross-functional teams on investigation excellence, technical writing, and regulatory expectations.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The collaborative investigator we seek has a biologics Drug Substance manufacturing and investigations background with strong cross-functional project management, regulatory presentation experience, and communication skills as well as the below qualifications.
Basic Qualifications:
Doctorate degree & 2 year of directly related experience
Or
Master's degree & 4 years of directly related experience
Or
Bachelor's degree or & 6 years of directly related experience
Or
Associate's degree & 10 years of directly related experience
Or
High school diploma / GED & 12 years of directly related experience
Preferred Qualifications:
- 7 + years related work experience (manufacturing, microbiology, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
- Demonstrated expertise leading complex investigations and assessing investigation quality, technical rigor, and regulatory compliance.
- Extensive experience with compliance, root cause analysis methodologies, quality risk management, CAPA effectiveness, and quality systems.
- Degree in Science or Engineering.
- Deep knowledge of FDA, EMA, and global GMP regulations, inspection expectations, and industry best practices related to investigation management and quality systems.
- Demonstrated success serving as a technical SME during regulatory inspections, internal audits, and inspection readiness activities.
- Experience using Veeva QMS for deviation investigations and CAPAs.
- Strong project and program management skills.
- Experience influencing senior leadership and driving site-wide quality initiatives.
- Demonstrated ability to mentor and develop investigators and technical professionals.
- Excellent written and verbal communication skills.
- Experience reviewing, authoring, or coaching complex deviation investigations to ensure technical rigor, regulatory compliance, and inspection readiness.
- Experience developing investigation narratives, storyboards, or technical presentations to effectively communicate quality events during audits and regulatory inspections.
- Experience preparing manufacturing personnel and subject matter experts for regulatory inspections, internal audits, or management reviews.
- Strong understanding of manufacturing operations, deviation management, CAPA systems, and inspection readiness principles.
- Ability to work effectively in a matrix environment and build strong cross-functional relationships.
Thrive
What you can expect of us
In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
- 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 and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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. Please contact us to request accommodation.
Salary Range
137,263.10USD -185,708.90 USD
