Associate Director, Quality Operations (Biologics)

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Job details

Bonus + Equity + REMOTE

This Jobot Job is hosted by Katie Griffith

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Salary $160,000 - $190,000 per year

A Bit About Us

We are a rapidly growing therapeutics 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
  
  

Job Details

We are looking for an Associate Director of Quality Operations who will provide laboratory QA support for our biologics commercial and clinical development programs by working closely with our various contract development and manufacturing organizations.

Our Quality Operations team consists of Lab QA, Manufacturing QA, and GMP/GDP Compliance functions. They are responsible for supporting all biologics CMC programs in compliance with our established procedures, cGMP, regulatory submissions, quality agreements, and other applicable guidelines and regulations.

Responsibilities

• Vendor management of contract laboratories. Facilitate routine external meetings, coordinate planning and delivery of testing results, lead implementation, and manage issue resolution.
• Review testing execution by CDMOs/CTLs, generate internal COAs, produce batch analysis and stability tables, and respond to emerging trend performance of drug substance and drug product across clinical and commercial CMC programs
• Capture records in Veeva for QMS activity at CDMO/CTLs, such as quality events, deviations, investigations, OOS/OOT, CAPA, Effectiveness checks, etc.
• Collaborate with Analytical Development group as needed, seeking additional technical support for test method implementation, troubleshooting, performance monitoring, and OOS/OOT investigations
• Drive change management in Veeva for implementation and modification of Quality testing related lifecycle documents (i.e. test methods, specifications, stability protocols, and related technical documents)
• Design and lead new initiatives and process improvements to Laboratory QA processes, including business tools, escalation norms, communication pieces
• Author, review, or approve lifecycle documents governing the Laboratory QA function, including SOPs, analytical methods, specifications, stability protocols/reports
• Review analytical method transfer/validation protocols, reports, and implementation plans
• Author and/or review APQRs, CTD sections of regulatory submissions, supplements, variations, and updates (e.g. BLA, IND, MAA, IMPD)
• Ensure critical reagents and reference standards are qualified and adequately supplied for clinical and commercial CMC programs
• Maintain compliant data integrity practices for document originated by CDMO/CTLs
• Participate in supplier qualification audits, due diligence, and/or health authority inspections of CDMO/CTLs
• Support product complaints, stock recovery/product recall, field alert and other quality events and regulatory actions as needed
• Author and/or review content of CDMO/CTL Quality Agreements
• Travel approximately 10% of the time (domestic and international).
  
  

Qualifications

• University degree in life sciences or related fields
• 10+ years’ experience in GMP Quality/QA/Quality Systems/ or Analytical Development in the biopharma/biologics/pharma industry
• Experience with data integrity assessments or remediation within an organization or at CMOs / CTOs
• Hands-on experience in providing Analytical, QC or Microbiology support for clinical and commercial manufacturing, tech transfers, product launches and ongoing commercial supplies
• Knowledge and expertise in principles and practices of cGMP for biologic drug substance, drug product and/or aseptic manufacturing experience is a plus
• Experience with CMO / CTO management (e.g. worked with or for CMOs / CTOs)
• Broad working knowledge of global regulations (i.e. ICH guidance, FDA/EMEA GMP regulations, etc.) for manufacturing, testing, packaging and distributing drug substances and drug products
• Direct interaction with FDA, EMA or other regulatory agencies during regulatory inspections is a plus
• Demonstrated ability to broadly assess regulatory compliance audit findings and implement appropriate CAPAs at CMOs / CTOs
• Experience with assessing validation requirements for laboratory, facilities and equipment
• The ability to manage multiple priorities with aggressive timelines and changing priorities
  
  

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