Sr cGMP Pharmaceutical Manager

Fresenius Medical Care • Tampa, FL

2d

About The Position

The Quality Manager, cGMP Pharmaceutical Products oversees and supports quality assurance at pharmaceutical and drug manufacturing sites, ensuring compliance with 21 CFR Parts 4, 210, and 211 and applicable ICH guidelines. The role provides strategic and operational cGMP quality leadership across systems and processes such as batch disposition, CAPA management, validation, supplier quality, regulatory inspections, and management reviews. It partners with Manufacturing, Regulatory Affairs, Supply Chain, and R&D to embed a quality culture and support an uninterrupted, compliant supply of pharmaceutical and drug products.

The position provides cGMP guidance and solutions across pharmaceutical and drug sites, assesses whether requirements are effective and followed, analyzes quality data and events, and escalates critical issues. It contributes to management reviews and continuous improvement, supports regulatory inspections and audit readiness, and helps develop responses to FDA observations and Warning Letters. The role may require coordination across North American time zones, response to urgent quality or regulatory events outside standard hours, and travel up to 15% as required.

Requirements

• Bachelor’s degree in chemistry, Pharmaceutical Sciences, Chemical Engineering, Biology, or a related scientific discipline.
• At least 10 years of quality assurance experience in pharmaceutical drug product manufacturing.
• At least 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.
• Deep expertise in 21 CFR Parts 4, 210, and 211.
• Strong working knowledge of ICH guidelines Q7, Q8, Q9, Q10, and Q11.
• Proficiency with electronic quality management systems, such as SAP, QMS, qTrack, or Agile.

Nice To Haves

• Master’s degree or advanced technical degree.
• Familiarity with contract manufacturing organization (CMO) oversight.
• Experience with statistical process control (SPC), process capability analysis, and quality risk management under ICH Q9.
• Familiarity with FDA guidance documents on process validation, data integrity (21 CFR Part 11), and pharmaceutical quality systems.
• Knowledge of EU GMP Annex requirements for global supply programs.

Responsibilities

• Lead and demonstrate cGMP knowledge and expertise, including applying cGMP requirements and providing training.
• Develop solutions and resolutions for effective deployment of quality systems and processes.
• Participate in FDA inspections and other regulatory audits.
• Engage with and support pharmaceutical and drug manufacturing sites to ensure cGMP requirements are met.
• Provide guidance on pharmaceutical and drug-related processes, system improvements, and changes.
• Work with manufacturing sites and site quality personnel to ensure requirements and compliant procedures are in place and followed.
• Assess the effectiveness of pharmaceutical and drug requirements at manufacturing sites.
• Provide independent input on in-process and finished-product results, as appropriate.
• Analyze deviations, out-of-specification results, complaints, and audit findings to identify systemic quality issues.
• Escalate critical quality issues promptly to senior leadership and Regulatory Affairs.
• Provide input to Management Reviews in accordance with ICH Q10 and site QMS requirements.
• Compile and present Management Review data, including CAPA trends, deviation metrics, audit outcomes, product quality reviews, regulatory intelligence, and resource assessments.
• Maintain compliant, audit-ready Management Review records and appropriate retention; use review outcomes to guide continuous improvement priorities and resource allocation.
• Analyze product and process data trends to assess the state of control and identify improvement opportunities.
• Manage the change control program where appropriate.
• Serve as a quality representative during FDA pre-approval, surveillance, and for-cause inspections.
• Prepare sites and personnel for regulatory inspections and develop and manage responses to FDA Form 483 observations and Warning Letters in collaboration with Regulatory Affairs.
• Perform other duties as assigned.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) with company match
• Paid time off
• Parental leave
• Potential performance-based bonuses depending on company and individual performance

What This Job Offers

• Job Type: Full-time
• Career Level: Senior