Director of Quality & Regulatory Affairs
About The Position
Silgan Unicep Packaging, a Silgan Dispensing company, is a premier liquid, gel, and cream contract manufacturer specializing in compounding/mixing, contract filling and designing custom unit-dose blow-fill-seal dispensers. Silgan Unicep serves a variety of customers in the medical diagnostic and imaging, consumer healthcare, oral healthcare, animal health markets. The Director of Quality and Regulatory Affairs (DQR) directs all quality assurance (QA), quality control (QC), and regulatory affairs (RA) functions. Reporting directly to the General Manager, the DQR ensures that all subcontracted and internal manufacturing activities meet current Good Manufacturing Practices (cGMP) and client-specific requirements while managing the lifecycle of drug, device, and cosmetic products from incoming materials to final product release.
Requirements
- Bachelor’s degree in STEM, or a related field.
- Minimum 10 years’ experience in cGMP Regulatory Affairs and/or Quality Assurance.
- Detailed knowledge of cGMP, ISO 9000, ISO 13485, and FDA requirements.
- Proven experience implementing quality systems in a cGMP environment.
- Excellent analytical and problem solving skills.
- Prior supervisory experience.
- Demonstrated leadership skills and ability to get results through others.
- Good communication and interpersonal skills.
- Proficient with Microsoft Office (Word, Excel, Project).
- Ability to manage multiple projects and prioritize to meet established timelines.
Nice To Haves
- Regulatory Affairs Certification (RAC) preferred.
- Auditing certification preferred.
Responsibilities
- Design and maintain a robust Quality Management System (QMS) aligned with 21 CFR Parts 210/211 and 820, EU GMP, and applicable ISO standards.
- Lead investigation, root cause analysis, and resolution for deviations, customer complaints, and non-conforming materials.
- Oversee validation activities and manage changes to processes, equipment, and/or materials.
- Oversee, review, and approve Master Batch Records (MBR) and make final disposition decisions for in-process and finished goods.
- Establish, implement, and enforce site-wide Good Documentation Practices (GDP).
- Define global regulatory pathways for client projects, including IND, NDA, and MAA filings. Lead eCTD dossier preparation and manage CMC (Chemistry, Manufacturing, and Controls) updates.
- Serve as the primary point of contact for regulatory agency (FDA, EMA) representatives and clients during inspections. Direct internal and supplier audit programs to ensure site readiness.
- Provide strategic and technical oversight of the Laboratory, ensuring all analytical testing for raw materials, in-process samples, and finished products complies with cGLP (Good Laboratory Practices).
- Partner closely with the Regulatory Affairs Manager to ensure the QMS and manufacturing outputs support all regulatory filings and functions.
- Act as a technical liaison for CMO clients, ensuring quality agreements are met and providing guidance on quality and regulatory hurdles for new product launches.
- Lead risk management activities across the product lifecycle. Monitor emerging 2025 regulatory trends, such as the use of AI/ML in regulatory processes and real-world evidence utilization.
- Manage departmental budgets and mentor a multi-disciplinary team of quality and regulatory professionals.
- Regular onsite attendance required.
- Adhere to company safety requirements.
Benefits
- Salary: $180,000 DOE
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What This Job Offers
Job Type
Full-time
Career Level
Director
