Senior Director, GMP Quality Assurance, Commercial
1 month ago
Description
Sr. Director, GMP Quality Assurance, Commercial
Position Summary:
The Senior Director Quality Assurance will provide expertise and guidance on Good Manufacturing Practice for all commercial products. They will adhere to applicable regulations and work with stakeholders to proactively identify compliance issues and risks and implement corrective actions, risk mitigation. They will have overall responsibility for the GMP QA Commercial team and daily commercial GMP operations at CMOs, including responsibility for quality management systems while ensuring internal systems are in compliance with GMPs and Company policies and procedures . They will work with internal functions and external vendors to promote a high level of quality. They will have overall responsibility for all GMP commercial vendors. They will support a company-wide culture of sustainable GMP and Quality compliance.
Essential Duties & Responsibilities:
- Provide expertise in GMP compliance interpretation, consultation, training, and recommendations.
- Assume complex assignments on issues where there is no precedent.
- Develop and implement risk based GMP audit and compliance strategy. Audits require advanced auditing skills and involve technically complex assignments. Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to Senior Management. Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures.
- Experience in implementing GMP inspection readiness program, including mock inspection activities.
- Demonstrated experience leading and hosting GMP audits, including health authority audits.
- Lead investigations into significant quality issues with focus on product impact and patient safety; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities, as appropriate.
- In collaboration with the Executive Director/Head of QA, lead GMP regulatory inspections; provide GMP compliance technical support during inspections. Facilitate appropriate and timely inspection responses and follow-up actions.
- Analyze, report, and present metrics to functional teams and Quality management; recommend any required actions and monitor implementation.
- Identify and mitigate GMP activities and process improvement initiatives as requested by management.
- Work closely with Quality Assurance team to ensure alignment and compliance with Quality Systems
- Self-motivating and independent.
- W ork independently and lead a high-performing team, with guidance from manager and senior staff.
- Must be able to articulate complex issues clearly verbally and written.
- Author, review, and/or approval documents including deviations, SOPs, and protocols.
Job Qualifications
Education, Certifications, Experience
- BS degree in scientific field required, advanced degree preferred.
- Minimum of 12 years of experience in the pharmaceutical industry, within QA/GMP environment.
- Minimum of 5 years managing high-performing teams, including mentoring and staff development
- Experience in data collection and metrics.
- Internal and external auditing experience, including lead auditor role.
- Small molecule experience required (drug substance/API, drug product, packaging and labeling) and QC/analytical.
- Must have experience working in cross-functional teams including, CMC, analytical, supply chain, and regulatory affairs, medical affairs, and commercial.
- Experience working with external vendors and suppliers including, drug substance/API, drug product, analytical, and/or secondary packaging and labeling.
- Experience managing QMS (including electronic systems), including documents and SOPs, change controls, deviations, product complaints, and annual product reviews.
- Oncology experience a plus.
- Hands-on manufacturing and/or laboratory experience a plus.
Professional Requirements
- Self-motivated leader with extensive knowledge and/or awareness of 21 CFR 210/211 and Part 11, ICH GMP, and applicable global regulations.
- Advanced knowledge in the conduct and reporting of audits, root cause analysis and the translation of findings into corrective actions plans that mitigate risks to product quality and GMP adherence.
- Experience preparing for and participating in GMP regulatory inspections.
- Strong technical writing skills; ability to write clear quality position statements, risk-based audit reports, and procedures.
- Excellent communication skills.
- Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines.
- Ability to rapidly synthesize complex issues and identify risks in a pragmatic way
- Extensive experience in building GMP systems and processes. Familiarity with Veeva a plus.
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