Manager, Quality & Pharmaceutical Affairs

About the role

The Manager, Quality & Pharmaceutical Affairs (MQPA) position supports the Quality and Regulatory Compliance of existing commercialized product portfolios: Dietary Supplements, and future products developed in the US. Key responsibilities include ensuring compliance with regulatory requirements, managing retailer standards, and overseeing product releases and quality control processes.

Responsibilities

• Collaborate with the Head of Pharmaceutical Affairs to establish and implement Quality and Regulatory Compliance objectives.
• Champion a culture of regulatory and quality compliance, leading continuous improvement efforts.
• Serve as the quality expert on cross-functional teams, providing guidance on quality and compliance matters.
• Assess, coordinate, prepare, and submit regulatory submissions to meet requirements (e.g., Gluten Free, NSF GMP certification, and non-GMO).
• Oversee inspection, testing, and release of all drug, dietary supplements, and natural health products.
• Manage the review and approval of all product packaging and labels, commercial and medical materials, and support collateral.
• Maintain and manage electronic repositories for all document retention.
• Conduct internal audits, supplier audits, and regulatory inspections as required.
• Work directly with operating entities (internal and CMOs/Testing Labs/3PLs) to ensure products meet all required quality standards, specifications, and ongoing performance is monitored and maintained.
• Oversee product releases, manage nonconformances, quarantine, discrepancies, and maintains retains program and sample traceability.
• Facilitate resolution of quality issues in a timely manner.
• Review and approve production records, specifications, test methods, validation and stability protocols and associated reports.
• Collaborate with stakeholders on deviation investigations, CAPA plans, root cause analysis effectiveness checks, trending, and escalations.
• Support pharmacovigilance AE reporting as backup to adverse event intake, medical triage, and tracking of AEs & product complaints.
• Facilitate cross-functional collaboration for creation and support of quality SOP’s.

Requirements

• 6+ years of experience in quality within the dietary supplement industry.
• FSPCA certification in Preventive Controls for Human Food (PCQI).
• ASQ certification preferred: Certified Quality Auditor (CQA), and/or Certified Pharmaceutical GMP Professional (CPGP).
• Extensive experience in the US market, with a focus on FDA regulations.
• In-depth knowledge of pharmaceutical quality systems, development, manufacturing, testing (including stability), and validation.
• Familiarity with relevant regulations and guidelines, including 21 CFR 210/211 and ICH Quality Guidelines.
• Strong communication skills, both written and verbal, with the ability to effectively present information to diverse audiences.
• Attention to detail, accuracy, and commitment to producing high-quality work.

Qualifications

• Bachelor's Degree in Chemistry, Biology, Engineering, or a related field.

Skills

• A reliable team-player with strong organizational, project management, detail-oriented, and communication skills.
• Proactive work style.
• Ability to be resilient, flexible, and adaptable to internal and external change.
• Autonomous and ability to work in a fast-changing and multi-tasking environment.
• Strong management and leadership capabilities.
• Excellent writing skills.

Travel

The US Quality position is associated with a minimum of 20% time in the field while customer-facing.

Additional Information

• Permanent/Non-Contract Full-Time Hybrid 2 days/week in Bedminster, NJ.
• Salary range: $90,000 to $120,000 commensurate with experience.
• Benefits: Medical, Dental, Vision, STD, LTD, Life, AD&D, 401k.
• This role is open to individuals with disabilities.