Senior Specialist, External Quality Operations
Mallinckrodt Pharmaceuticals
Summary
The Senior Specialist, External Quality Operations supports externally manufactured products for Keenova with a product portfolio that includes pharmaceutical and biopharmaceutical products. The position is responsible for building, maintaining and managing the relationship with their counterparts at the CMO and cross-functional team members. The position is responsible for appropriate escalation to Manager/Director level management and above.
Job description
Key Responsibilities
- Preparation, review and approval of CMO documentation for batch production
- Review of batch records, addressing discrepancies and escalating where required to management
- Preparation of disposition and release certification for reviewed batch records
- Management and oversight of third-party supplier activities relating to the manufacture, packaging and testing of product
- Regular telephone and email communication with CMOs to ensure timely manufacture and resolution of quality issues for product
- Continuous monitoring of product and performance from CMOs
- Quality record management; deviations, change controls, CAPAs
- Monitoring cold-chain transportation, for both qualification and routine
- CMO Maintenance
- Input into Technical Quality Agreements
- Post-launch support for quality activities in various countries, as needed
- Management of delegated projects
- Protocol review and approval
- Data review and management
- Drive the audit readiness program to always ensure audit compliance
- Champion continuous improvement efforts for projects identified at the CMOs or within Keenova
Qualifications
Bachelor’s Degree in scientific discipline, preferred +5-7 years’ experience working as a Quality Specialist.
Direct experience working with Quality Systems (deviations, change controls, training, supplier qualification and document management systems).
Preferred Skills: Knowledge of cGMP requirements for pharmaceutical manufacturing and knowledge of GDP and ISO 13485.
Requirements
- Bachelor’s Degree in scientific discipline
- 5-7 years’ experience working as a Quality Specialist
- Direct experience working with Quality Systems (deviations, change controls, training, supplier qualification and document management systems)
- Knowledge of cGMP requirements for pharmaceutical manufacturing
- Knowledge of GDP and ISO 13485
Benefits
- Competitive pay
- Total Rewards package
- Bonus eligible
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.