Associate Director, Quality Operations - Commercial Biologics

Job Description

Job Description

Bonus + Equity + 401(k) + REMOTE

This Jobot Job is hosted by : Katie Griffith

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Salary : $160,000 - $185,000 per year

A bit about us :

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.

Why join us?

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

Job Details

We are looking for an Associate Director (or Senior Manager) of Quality Operations to provide quality oversight for our biologics commercial programs.

The ideal candidate will have experience managing complex business relationships with QPs / EU business partners and expertise in drug product manufacturing.

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 in biopharma / biologics / pharmaceutical industry
• Experience working directly with contract manufacturing organizations (CMOs) is required
• Direct interaction with FDA, EMA or other regulatory agencies during regulatory inspections and qualified persons (QPs) is required
• Experience in biologics is required
• Experience in sterile drug product manufacturing is preferred
• Thorough knowledge of cGMP regulations
• 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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