Senior Manager, Quality Operations (Biologics Manufacturing)

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Salary: $130,000 - $160,000 per year

We are a rapidly growing biotherapeutics company with an approved drug on the market, leveraging scientific advances in B-cell biology to develop novel treatment for patients.

• Competitive Salary
• Annual Bonus
• Equity (RSUs)
• 401k Program
• REMOTE
• Health Benefits
• Commercial Drug
• REMOTE

We are looking for a Manager/Senior Manager of Quality Operations to provide quality oversight for our biologics commercial programs.

Responsibilities:

• Ensure CMO compliance with applicable cGMP regulations, batch records, product registrations, quality agreements and data integrity standards
• Support QA batch record reviews and lot dispositions of commercial drug substance and drug product per established procedures for internal and business partner use
• Lead quality aspects and provide support to our business partners on QA-related investigations, change controls, lot dispositions, and regulatory requests
• Lead quality aspects and provide support to CMOs in QA-related investigations, change controls, documentation and regulatory requests.
• Conduct and review product and/or lot-related deviations, complaints, CAPAs, change controls and annual product quality reviews (APQRs).
• Review and approve controlled documents, including commercial manufacturing and packaging master batch records, protocols and final reports
• Work with our Quality Systems and CMC teams to ensure quality and technical documentation is delivered to the internal archiving system
• Provide guidance, advice, and support for GMP quality and compliance matters.
• Represent Quality as PIP at CMO’s as necessary to support production operations.
• Demonstrate high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained. Contribute to development and improvement of our Quality System as relevant, such as creation and updating of SOPs
• Participate in developing, reporting, reviewing, and trending of GMP-related Quality Metrics such as Key Performance Indicators (KPIs) in support of the QMS.
• Travel approximately 10% of time (domestic and international)

Qualifications:

• University degree in life sciences or related fields
• 5+ years' experience in GMP Quality or Manufacturing in biopharma/biologics/ pharmaceutical industry
• Experience in biologics is required
• Experience working directly with contract manufacturing organizations (CMOs) is required
• Experience in sterile drug product manufacturing is preferred
• Thorough knowledge of cGMP regulations; direct interaction with FDA, EMA or other regulatory agencies during regulatory inspections and qualified persons (QPs) is preferred
• Experience supporting commercial and lifecycle management
• Experience in oversight of contract manufacturing
• Proficiency in electronic QMS Software such as Veeva, Trackwise, etc.
• Excellent attention to detail, organizational and time management skills
• Must have strong written and oral communication skills

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