Associate Director, GMP Quality Assurance

Company: Kinsley Power Systems
Location: Cambridge
Posted on: November 6, 2024

Job Description:

Associate Director, GMP Quality Assurance
Who we are:
is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for rare diseases - and make a bigger difference in their lives. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company's leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.
The impact you will make:
Agios Pharmaceuticals is searching for a dynamic Associate Director to join our growing GMP Quality Assurance team. We want someone who cares about this important work, and who's driven to connect to our mission of helping these patient communities. The Associate Director will be responsible for lot review/release activities for commercial drug substances and bulk drug products manufactured by Contract Manufacturing Organizations (CMOs). This Quality Assurance professional will assure the company, its affiliates and/or contractors associated with the manufacture, packaging, labeling, testing and distribution of products used for Phase III/process validation through commercial phases comply with cGMPs and standards as well as regulations of applicable authorities. The AD will have one direct report at Sr. Manager level also responsible for drug substance and bulk drug product and should provide guidance, learning and development opportunities, feedback, and opportunities for independence.
What you will do:

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• Manage direct report, provide leadership, mentorship, and direction
  
• Execute commercial product release activities for drug substance and bulk drug product (batch and continuous manufacturing) including review and approval of Master Batch Records along with executed batch records. Provide back-up for commercial finished goods product release on as needed basis
  
• Provide Quality oversight and represent Agios QA on external CMO project teams. Manage relationships with CMOs. This may include periodic visits to CMOs, as required
  
• Coordinate QP release as appropriate
  
• Effectively interact with external contract manufacturers as well as work as part of an internal multidisciplinary team to support manufacturing, testing, and product complaint investigations
  
• Manage and address associated investigations, CAPAs, change controls, OOS, Material Review Boards, etc. for commercial products
  
• Implement necessary Quality Agreements
  
• Assist in preparing or reviewing CMC sections of regulatory submissions and collecting related CMO source documents
  
• Review and approve Annual Product Reviews (Vendor and Internal)
  
• Conduct or support audits of CMOs
  
• Provide QA support for regulatory inspections
  
• Provide QA expertise in the development of Agios quality systems, processes and procedures
  
  What you bring:
  
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  • Bachelor's degree in biology, chemistry, life sciences or a related field
    
  • 10+ years of direct Quality Assurance experience in a cGMP environment
    
  • Commercial and process validation experience strongly preferred
    
  • Strong knowledge of cGMP regulations, practices and trends pertaining to pharmaceutical product development, manufacturing, testing, and commercial operations.
    
  • Exercises judgment within broadly defined practices and policies in determining solutions and actions
    
  • Demonstrates ability to identify and recognize quality issues that will result in critical delays in schedule or operations and may jeopardize overall business activities
    
  • Knowledge of small molecule drug substance, drug product solid dosage manufacturing principles, equipment, and processes. Continuous manufacturing knowledge a plus
    
  • Experience managing a direct report
    
  • Experience working with CMOs preferred
    
  • Knowledge of packaging and finished goods a plus
    
    Work Location:
    Location Agnostic: Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.
    What we will give you:
    
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    • Deliberate Development. Your professional growth as one of our top priorities.
      
    • Flexibility. We're all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you're at your best, we're at our best.
      
    • Premium benefits package. We invest in the health, wellbeing and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team.
      
    • Competitive performance-based compensation. This includes both short- and long-term incentives that are connected to our business strategy.
      
    • Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
      
    • Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We're continuously looking to improve the inclusivity of our workforce.
      
    • Commitment to community. We're an active participant in the communities that surround us - the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.
      
      Interested in learning more about what makes our culture unique? Visit the section of our website.
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Keywords: Kinsley Power Systems, Portland , Associate Director, GMP Quality Assurance, Executive , Cambridge, Maine