Senior Manager, Clinical Product Quality - United States
Position Can be Based in New Haven, CT or Smithfield, RI
The Clinical Product Quality Sr. Manager is responsible for managing and supporting GMP Quality oversight for all external Active Pharmaceutical Ingredient (API) and Drug Product manufacturing activities for Global Clinical Supply products to ensure compliance with current Good Manufacturing Practices (cGMPs). This includes daily QA oversight of third party contractor operations for New Product Introduction activities, Tech Transfer, Cell Bank development, and Clinical product manufacturing, testing, shipping, and storage. Leads implementation of strategic initiatives to realize Quality objectives. Ensures progress and drives completion of milestones associated with: Contract Manufacturing Organization (CMO) oversight, API and Drug Product Disposition and quality systems including Change Control, Deviations, and CAPAs. Uses judgement to develop solutions to a variety of complex quality events and issues. Drives Quality Risk Management and Continuous Improvement initiatives to ensure compliance to GMPs. Performs all responsibilities in accordance with company policies, procedures, and federal regulations.
- Ensures continuous improvement of Quality and Compliance for Alexion’s global external API and Drug Product manufacturing activities against internal policies and procedures as well as domestic and international GMP regulations.
- Partners with internal cross-functional areas, such as Technical Manufacturing Services, Global Clinical Supplies, and Regulatory Affairs to manage a best in class GMP Quality Assurance program by strengthening the organization’s operational excellence in support of continued growth.
- Participates on Global Operational Project Teams in support of operational planning and Clinical Supply operations release strategies as needed.
- Acts as QA Operations management lead support for Product Development, New Product Introduction, and Tech Transfer activities for clinical product.
- Provides quality oversight of CMOs including maintaining Quality Agreements, Quarterly Quality Reviews, Risk Management, decision-making during packaging operations and distribution activities, and on-site support as needed.
- Develops and maintains necessary Standard Operating Procedures (SOPs) and Key Performance Indicators (KPIs) to manage internal processes and CMOs for all API and Drug Product manufacturing activities, applies Right-First-Time (RFT) initiatives, increases efficiency, mitigates risks and realizes expected quality and supply outcomes.
- Supports review of GMP API and Drug Product contract manufacturing, testing, and shipping batch records and performs final quality decision for lot disposition to certify compliance with specifications and procedures and ensures product is delivered on time of supply need.
- Provides support for requests from Qualified Persons to ensure release of product, including post-disposition notifications.
- Ensures change controls related to all external API and Drug Product manufacturing activities for clinical product are authorized in accordance with procedures, works cross-functionally to ensure effective implementation against regulatory approval requirements and project timelines, and performs final quality decision for making the change effective and closure.
- Reviews and assesses deviations related to all external API and Drug Product manufacturing activities for clinical product; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending and performs final quality decision.
- Review and approves Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting / trending and evaluating CAPA for effectiveness.
- Ensures deployment of GMP training to site personnel and contractors on Quality System Procedures and systems.
- Ensures regulatory inspection readiness and provides QA expertise & support to internal and external Regulatory inspections.
- Provide expertise from a technical perspective on internal / external GMP audits of facilities and systems and works to resolve audit observations as required.
- Ensures timely escalation to Management of critical quality issues.
- Minimum of 10 - 12 years cGMP related experience in biopharmaceutical / pharmaceutical or related industry with 7 – 10 years direct QA experience in a cGMP environment
- Thorough knowledge of domestic/international regulatory requirements related to cGMP operations
- Experience with respect to finished product packaging and distribution for clinical supplies used in phase I through phase IV clinical trials as well as commercial product
- Experience with medical devices desirable
- Experience performing lot disposition activities, managing quality events and issues, and supporting systems related audits is essential
- Experience with electronic Quality Management systems such as SAP, TrackWise, firstDocs, etc.
- Operational Excellence certification is preferred (Lean Six Sigma Green or black belt)
- Willingness to travel (up to 20%)
Minimum of a BS/BA degree in Chemistry, Biology or related field required, Master’s a plus
New Haven, CT, United States
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /Affirmative action employer