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.
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.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Quality Management System (QMS) Leadership: Design and maintain a robust Quality Management System (QMS) 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 (MBR) 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 (GDP).
- Regulatory Strategy & Submissions: 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.
- Audit and Inspection Management: 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.
- 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 (Good Laboratory Practices).
- 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 2025 regulatory trends, such as the use of AI/ML in regulatory processes 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.
MINIMUM 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.
PHYSICAL REQUIREMENTS:
- 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
LIMITATIONS AND DISCLAIMER
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position.
All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees.
This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow any other job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws.
Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently. Continued employment remains on an “at-will” basis.
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.
