Senior Manager, Quality Assurance
Mallinckrodt Pharmaceuticals
Summary
The Senior Manager, Quality Assurance is responsible for the direct oversight, management, and execution of Quality Operations and Quality Systems activities at the Cranbury, NJ, and Rye, NY facilities, ensuring compliance with current Good Manufacturing Practices (cGMP), FDA regulations, applicable international quality standards, and company policies and procedures.
Job description
Quality Operations
- Provides leadership and oversight for Quality Operations for quality floor operations including manufacturing floor quality support, line clearance activities, product sampling, incoming material inspection, material disposition, and batch release activities.
- Oversees the review and approval of raw materials, in-process materials, and finished product batches to ensure compliance with cGMP requirements and internal quality standards.
- Reviews and approves product stability data and supports stability program management.
- Directs batch record review and batch data review activities to ensure product quality and regulatory compliance.
- Develops, implements, and maintains Quality Assurance procedures, policies, and processes to support compliant operations and continuous improvement.
- Provides oversight of the site's environmental monitoring program including routine monitoring, annual requalification activities, and post-maintenance requalification of manufacturing rooms and other classified plant areas.
- Manages Quality Assurance owned equipment and ensures appropriate calibration, preventative maintenance, and life cycle management activities are completed in accordance with established procedures.
Compliance & Management
- Leads and contributes to the development, management, harmonization and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations and company quality standards in support of cGxP activities.
- Leads deviation investigations, root cause analyses, corrective and preventive actions (CAPAs), and effectiveness monitoring in the Quality and Manufacturing areas.
- Leads non-conforming material investigations and product quality issues.
- Reviews and approves OOS/Laboratory investigations.
- Leads or supports regulatory inspections, customer audits, and internal audits while ensuring inspection readiness.
- Responsible for the maintenance of the Quality Management System and ongoing effectiveness and compliance.
- Manages Quality Agreements with contract manufacturers, suppliers, vendors, and business partners.
- Responsible for plant Risk assessment programs.
- Ensures the effectiveness of the site's GxP training program and quality compliance training initiatives.
Product Quality Review & Regulatory Support
- Oversees and contributes to the preparation and approval for Annual Product Reviews/Product Quality Reviews.
- Reviews and approves updates for regulatory filing(s), as applicable.
- Prepares, reviews, and approves controlled documents relevant to GxP operations.
- Develops quality metrics and reports for site leadership and management review.
Requirements
- Bachelor's degree in a scientific, engineering, or related technical discipline required; advanced degree preferred.
- Minimum of 8+ years of progressive experience in Quality Assurance, Compliance, and Quality Systems within the pharmaceutical industry.
- Previous Biologics, Biotechnology, and Pharmaceutical or Biopharmaceutical experience.
- At least 3-5 years of people leadership experience.
- Industry experience with or knowledge of terminally sterilized and/or aseptic operations is required.
- Experience in maintaining cGMP compliance a must; implementing a plus.
- Strong knowledge of current Good Manufacturing Practices (cGMP), applicable FDA regulations, ICH guidelines, and quality systems requirements.
- Working knowledge of Quality Management Systems (QMS), including deviations, CAPA, change control, risk management, training, complaints, and audit management.
- Knowledge of biologics, pharmaceutical, biotechnology, and/or combination product manufacturing processes.
- Understanding of regulatory inspection practices and requirements, including FDA and other global regulatory agency expectations.
- Knowledge of aseptic processing, environmental monitoring, and contamination control principles preferred.
- Familiarity with data integrity requirements and industry best practices.
- Ability to influence, collaborate, and build effective partnerships across Quality, Manufacturing, Regulatory Affairs, Supply Chain, and Technical Operations.
- Strong communication and interpersonal skills, with the ability to effectively interact with all levels of the organization, external partners, auditors, and regulatory agencies.
- Demonstrated ability to manage multiple priorities and drive results in a fast-paced, regulated environment.
- Strong analytical, critical thinking, decision-making, and problem-solving skills.
- Effective project management and organizational skills with the ability to lead complex quality initiatives.
- Strong technical writing and documentation review skills.
- Ability to lead investigations, perform risk assessments, and drive continuous improvement initiatives.
- Demonstrated leadership presence with the ability to influence decisions, manage change, and achieve business objectives through collaboration and negotiation.
Benefits
- Competitive pay
- Bonus program
- Medical, Dental & Vision
- 401(k) Matching
- Paid Time Off
Company overview
Mallinckrodt Pharmaceuticals is a global specialty pharmaceutical company founded in 1867 with headquarters in Dublin, Ireland, and operational headquarters in the United States. The company develops, manufactures, markets, and distributes specialty pharmaceutical products and therapies across two main segments: Specialty Brands and Specialty Generics. The Specialty Brands segment focuses on autoimmune and rare diseases in areas such as neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology, as well as immunotherapy, neonatal respiratory critical care therapies, analgesics, and gastrointestinal products. The Specialty Generics segment includes specialty generic drugs and active pharmaceutical ingredients. Mallinckrodt is particularly known for its flagship product Acthar Gel, a naturally sourced complex mixture of adrenocorticotropic hormone analogs used to treat various autoimmune disorders and medical conditions known to cause inflammation. The company has approximately 1,001-5,000 employees worldwide and operates with a direct sales presence in roughly 50 countries. Mallinckrodt has faced significant legal challenges related to opioid litigation and pricing controversies surrounding Acthar Gel, leading to bankruptcy filings in 2020 and 2023. In 2025, the company announced a merger with Endo to create a larger, diversified pharmaceuticals leader.