Director of Quality & Regulatory Affairs

OBJECTIVE

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.

• Quality Management System (QMS) Leadership: Design and maintain a robust Quality Management System aligned with 21 CFR Parts 210/211 and 820, EU GMP, and applicable ISO standards.
• Deviation and CAPA Management: Lead investigation, root cause analysis, and resolution for deviations, customer complaints, and non‑conforming materials.
• Validation and Change Control: Oversee validation activities and manage changes to processes, equipment, and/or materials.
• Batch Record Review and Release: Oversee, review, and approve Master Batch Records (M ) and make final disposition decisions for in‑process and finished goods.
• Documentation Governance and Data Integrity: Establish, implement, and enforce site‑wide Good Documentation Practices.
• Regulatory Strategy & Submissions: Define global regulatory pathways for client projects, including IND, NDA, and MAA filings. Lead eCTD dossier preparation and manage CMC updates.
• Audit and Inspection Management: Serve as the primary point of contact for regulatory agency representatives and clients during inspections. Direct internal and supplier audit programs to ensure site readiness.
• Laboratory Governance: Provide strategic and technical oversight of the Laboratory, ensuring all analytical testing for raw materials, in‑process samples, and finished products complies with cGLP.
• Regulatory Compliance and Technical Support: Partner closely with the Regulatory Affairs Manager to ensure the QMS and manufacturing outputs support all regulatory filings and functions.
• Strategic Client Partnership: 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.
• Risk & Compliance Monitoring: Lead risk management activities across the product lifecycle. Monitor emerging regulatory trends, such as the use of AI/ML and real‑world evidence utilization.
• Team Leadership: Manage departmental budgets and mentor a multi‑disciplinary team of quality and regulatory professionals. Regular onsite attendance required; adhere to company safety 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.
• Regulatory Affairs Certification (RAC) preferred; auditing certification preferred.
• 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.

Frequently required to sit, talk, and hear. Frequently required to stand and walk. Occasionally required to lift up to 20 pounds (9 kg).

Vision ability including close vision, distance vision, color vision and the ability to adjust focus. Ability to travel occasionally by air or car to attend business meetings and conduct audits.

Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.

Salary: $180,000 DOE

Silgan is an Equal Opportunity Employer. We consider applicants for all positions without regard to race, color, religion, sex, national origin, age, marital status, or the presence of a disability, which would not prevent the performance of essential job duties with, or without reasonable accommodation of any other protective status. Silgan is a drug‑free workplace.