Senior cGMP Pharmaceutical Manager

This is a fully remote position, open to applicants in Florida, +7 more states.

📋 Description

• Supervise and facilitate quality assurance functions at pharmaceutical and drug manufacturing locations.

• Offer strategic and operational quality leadership regarding cGMP across batch disposition, CAPA management, validation, supplier quality, regulatory inspections, management reviews, and associated systems and processes.

• Collaborate with Manufacturing, Regulatory Affairs, Supply Chain, and R&D to instill a culture of quality and guarantee a consistent, compliant supply.

• Lead and exhibit cGMP knowledge and expertise, including providing training.

• Develop solutions and resolutions for implementing quality systems and processes.

• Participate in FDA inspections and other regulatory audits.

• Engage and assist pharmaceutical/drug sites to ensure adherence to cGMP requirements.

• Direct improvements and modifications to pharmaceutical/drug-related processes and systems.

• Work alongside manufacturing sites and quality personnel to ensure compliance with requirements, procedures, and adherence standards.

• Evaluate the effectiveness of pharmaceutical/drug requirements at various sites.

• Provide independent insights into in-process and finished product results, as necessary.

• Analyze deviations, out-of-specification (OOS) results, complaints, and audit findings to pinpoint systemic quality issues.

• Report critical quality concerns to senior leadership and Regulatory Affairs.

• Contribute to Management Reviews in line with ICH Q10 and site QMS requirements.

• Gather and present Management Review data, including CAPA trends, deviation metrics, audit outcomes, product quality evaluations, regulatory intelligence, and resource assessments.

• Maintain compliant, audit-ready Management Review documentation and utilize outcomes for continuous improvement and resource allocation.

• Examine product and process data trends to evaluate control status and identify areas for enhancement.

• Oversee the change control program as appropriate.

• Act as the quality representative during FDA pre-approval, surveillance, and for-cause inspections.

• Prepare sites and staff for regulatory inspections.

• Develop and manage responses to FDA Form 483 observations and Warning Letters in collaboration with Regulatory Affairs.

• Perform additional duties as assigned.

⛳️ Requirements

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biology, or a related scientific field (required).

• At least 10+ years of quality assurance experience in pharmaceutical drug product manufacturing.

• A minimum of 5+ years in a senior QA leadership role with direct management responsibilities.

• Practical experience with FDA inspections, including responses to Form 483 and remediation efforts.

• Proven experience leading Management Reviews and presenting to site and executive leadership.

• Extensive knowledge of 21 CFR Parts 4, 210, and 211.

• Strong familiarity with ICH guidelines: Q7, Q8, Q9, Q10, Q11.

• Proficient in eQMS platforms (e.g., SAP, QMS, qTrack, Agile, etc.).

• Experience with oversight of contract manufacturing organizations (CMO) is advantageous.

• Knowledge of statistical process control (SPC), process capability analysis, and quality risk management (ICH Q9) is beneficial.

• Awareness of FDA guidance documents related to process validation, data integrity (21 CFR Part 11), and pharmaceutical quality systems is a plus.

• Understanding of EU GMP Annex requirements is beneficial for global supply programs.

• Capability to work across time zones for coordination among North American multi-sites.

• Ability to respond to urgent regulatory or quality issues outside of standard hours.

• Willingness to travel up to 15% as needed.

🏝️ Benefits

• Medical, dental, and vision insurance.

• 401(k) plan with company matching.

• Paid time off.

• Parental leave.

• Opportunity for performance-based bonuses based on company and individual performance.

• Reasonable accommodation for individuals with disabilities.