Impress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Tailor your resume to this Sr cGMP Pharmaceutical Manager role.
Rezi rewrites your resume against Fresenius Medical Care's job description. Free.
Tailor your resume to this Sr cGMP Pharmaceutical Manager role.
Rezi rewrites your resume against Fresenius Medical Care's job description. Free.
Don't guess if your resume is good enough.
See how it scores against the Sr cGMP Pharmaceutical Manager posting at Fresenius Medical Care — free, in seconds.
Don't guess if your resume is good enough.
See how it scores against the Sr cGMP Pharmaceutical Manager posting at Fresenius Medical Care — free, in seconds.
About the Role
Oversees and supports quality assurance responsibilities at pharmaceutical/drug manufacturing sites, ensuring full compliance with 21 CFR Parts 4, 210, 211, and applicable ICH guidelines. Provides cGMP strategic and operational quality leadership across systems and processes including batch disposition, CAPA management, validation, supplier quality, regulatory inspections, and management reviews. Partners with Manufacturing, Regulatory Affairs, Supply Chain, and R&D to embed a culture of quality and ensure compliant supply of pharmaceutical/drug products.
Responsibilities
- Leads and demonstrates cGMP knowledge and expertise, including its application and training.
- Provides solutions and resolutions on how best to deploy systems and processes.
- Actively participates in FDA inspections and other regulatory audits.
- Actively engages and supports all pharma/drug sites to ensure cGMP requirements are met.
- Provides guidance on all pharma/drug related processes and system improvements and changes.
- Ensures, by working with manufacturing sites and site quality personnel, that all pharma/drug requirements are in place and procedures are compliant and being followed.
- Assesses the effectiveness of pharma/drug requirements at sites.
- Provides independent inputs into in-process and finished product results.
- Performs analysis of deviations, OOS results, complaints, and audit findings to identify systemic quality issues.
- Escalates critical quality issues to senior leadership and regulatory affairs in a timely manner.
- Provides inputs into Management Reviews in accordance with ICH Q10 and site QMS requirements.
- Compiles and presents comprehensive Management Review input data including CAPA trends, deviation metrics, audit outcomes, product quality reviews, regulatory intelligence, and resource assessments.
- Maintains compliant, audit-ready Management Review records with appropriate retention.
- Uses Management Review outcomes to drive continuous improvement priorities and resource allocation decisions.
- Analyzes product and process data trends to assess the state of control and identify improvement opportunities.
- Manages the change control program where appropriate.
- Serves as a quality representative during FDA pre-approval inspections (PAIs), surveillance inspections, and for-cause inspections.
- Prepares site and personnel for regulatory inspections.
- Develops and manages responses to FDA Form 483 observations and Warning Letters in collaboration with Regulatory Affairs.
- Performs other duties as assigned.
Requirements
- Ability to work across time zones for North American multi-site coordination.
- May require response to urgent regulatory or quality events outside of standard hours.
- Minimum 10+ years of quality assurance experience in pharmaceutical drug product manufacturing.
- Minimum 5+ years in a senior QA leadership role with direct people management responsibility.
- Hands-on experience with FDA inspections including Form 483 responses and remediation.
- Demonstrated experience leading Management Reviews and presenting to site and executive leadership.
- Familiarity with contract manufacturing organization (CMO) oversight is a plus.
- Deep expertise in 21 CFR Parts 4, 210 and 211.
- Strong working knowledge of ICH guidelines: Q7, Q8, Q9, Q10, Q11.
- Experience with statistical process control (SPC), process capability analysis, and quality risk management (ICH Q9) is a plus.
- Familiarity with FDA guidance documents on process validation, data integrity (21 CFR Part 11), and pharmaceutical quality systems is a plus.
- Knowledge of EU GMP Annex requirements is advantageous for global supply programs is a plus.
- Proficiency in eQMS platforms (e.g., SAP, QMS, qTrack, Agile etc).
Skills
- cGMP knowledge
- Quality assurance
- Batch disposition
- CAPA management
- Validation
- Supplier quality
- Regulatory inspections
- Management reviews
- Statistical process control (SPC)
- Process capability analysis
- Quality risk management
- Process validation
- Data integrity
- Pharmaceutical quality systems
- eQMS platforms
Work Type
- Full-time
Experience Level
- 10+ years of quality assurance experience
- 5+ years in a senior QA leadership role
Education Level
- Bachelor’s degree in chemistry, Pharmaceutical Sciences, Chemical Engineering, Biology, or related scientific discipline
- Master’s degree or advanced technical degree preferred
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) with company match
- Paid time off
- Parental leave
- Potential for performance-based bonuses
About the Company
- Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.
Equal Opportunity
- Fresenius Medical Care is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sexual orientation, gender identity, parental status, national origin, age, disability, military service, or other non-merit-based factors.