Research Associate II / Senior Research Associate, Cellular Biology Assay Development Research Associate in vivo Pharmacology
SENIOR MANAGER / ASSOCIATE DIRECTOR QUALITY ASSURANCE

BRIS.138

The Senior Manager/Associate Director of Quality Assurance will play a leadership role in establishing the company’s Quality Assurance program focused on conducting internal and external Good Manufacturing Practice (GMP) oversight to and management of Starting Material, Drug Substance, Drug Product contract manufacturing organizations

Roles and Responsibilities

  • Provides quality oversight for outsourced manufacturing, testing and, packaging activities including executed batch records, AQLs, investigations, operation start-up, and packaging line trials
  • Leads weekly QA to QA meetings and represents QA in weekly meetings with CMOs
  • Drives, leads, and troubleshoots deviation and product investigations as needed.
  • Review and approve master batch records for contract manufacturing organization regulatory starting material, drug substance, drug product, and clinical labeling & packaging operations
  • Review and approve change requests to ensure proposed changes are clearly described, justified, and verified as completed.
  • Perform QA approval of deviation investigations
  • Support or perform internal and supplier qualification audits, as requested
  • Review data for and/or sections of regulatory submissions
  • Perform complaint investigations
  • Communicate/collaborate with Unity Subject Matter Experts and contract manufacturing organizations on quality related issues supporting QA
  • Maintain QA Operations logs, databases, and generate Quality metrics
  • Review and disposition of clinical production lots. Review of executed production records, and QC testing results to determine disposition decisions (starting API, API, excipients, drug product, placebo, etc.)
  • Organize/Archive executed batch record documentation: manufacturing records, analytical data documentation, labelling and packaging records
  • GMP/QA review of QC stability and test method protocols and reports.
  • Development of Quality Agreements
  • Project Leadership and management of multiple CMO/CRO activities and manufacturing operations for projects under development (from API starting material through Drug Product), including Technology Transfer.
  • Participate in the process for selecting appropriate CRO/CMO and monitoring performance
  • Development and Implementation of the Unity Quality System
  • Report writing including product life cycle reports, investigation reports, change controls, protocols, development reports, regulatory filings
  • Batch Record Analysis/review, SOP preparation and review, data collection/trending, quality and supply agreement evaluation, and analysis of CMO/CRO procedures
  • Manage data and reports, agreements, batch records, procedures w/GMP Starting Material and API, and DP manufactures
  • Planning and tracking of activities and spend with
  • Lead sub-groups, serve as Unity Quality representative, and collaborate with other departmental functions w/in Unity
  • Person in Plant as needed
  • Other Responsibilities as needed and assigned by supervisor

REQUIREMENTS:

  • Bachelor’s degree in biological sciences, chemistry, or related field, or equivalent experience; Master’s degree preferred.
  • Minimum 10 years progressive experience in pharmaceutical or biopharmaceutical industry
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
  • Proven track record of successful project management, cross functional collaboration, especially with foreign based CRO/CMO projects where daily oversight, budget and timelines were achieved.
  • Strong PM, verbal communication and written communication skills
  • Knowledgeable in current GMP/GLP and regulatory requirements (US, Canada, EU)
  • Experience with lifecycle product management
  • Extremely motivated individual able to work with other Operations areas (Manufacturing, Technical Operations, Supply Chain, Regulatory CMC) involved in drug development and manufacturing to solve complex problems
  • Be a team player in a dynamic fast paced virtual biotechnology environment where collaboration and partnership is the norm
  • ASQ Certified Quality Auditor preferred
  • Strong working knowledge of and ability to apply GMP in conformance to US, EU, and ROW standards
  • Experience auditing external suppliers and/or internal GMP systems
  • Self-motivated, detail oriented, and willing to accept temporary responsibilities outside of initial job description
  • Travel Requirement 10-40%

Please send resume and cover letter