This role is responsible for managing internal audit programs and external supplier audits, while ensuring compliance with cGMP standards and regulatory requirements.
Key Responsibilities- Lead and manage internal (Business Management) audits and external supplier audit programs.
- Serve as an auditor for site internal audits and supplier audits.
- Develop and maintain the annual audit plan, including facilitating periodic review meetings with management.
- Conduct audit close-out meetings to communicate findings and expectations to stakeholders.
- Prepare, issue, and maintain internal and supplier audit reports using standardized formats.
- Review audit responses for adequacy, identify gaps, and work with owners to resolve discrepancies.
- Coordinate and track CAPAs (Corrective Actions) associated with audit findings to ensure timely completion.
- Monitor audit commitments and ensure adherence to established response timelines.
- Generate and distribute monthly reports on outstanding audit commitments and CAPA status.
- Perform follow-up activities to verify implementation and effectiveness of corrective actions.
- Provide guidance to site personnel on cGMP compliance and regulatory expectations.
- Support preparation for regulatory inspections, corporate audits, and customer audits.
- Assist with audit observation follow-up related to regulatory inspections and global quality audits.
- Interpret and communicate current regulatory requirements and industry guidance to internal stakeholders.
- Collect, analyze, and report site Quality metrics and support quality trending activities within required timelines.
Qualifications- Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, or related field)
- Experience in a cGMP-regulated environment (biopharmaceutical industry preferred)
- Strong knowledge of auditing practices and CAPA management
- Familiarity with FDA and global regulatory expectations
The anticipated salary range for this position in Maryland is $99,825 to $133,100 plus annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.
Benefits:
• 13 paid holidays
• Vacation time
• 401K match
• Medical, dental and vision benefits effective day one of employment
