GMP Quality Assurance Manager

DEPARTMENT: Quality Assurance
LOCATION: San Diego, CA
MANAGER: Director, QA
TYPE: Full Time, Permanent

SUMMARY OF RESPONSIBILITIES: 

The GMP QA Manager provides quality oversight and ensure GMP compliance during the manufacture, packaging, and testing of drug substance and drug product, including packaging and labeling of clinical trial materials. This position will conduct and manage the review and disposition of drug substance and drug product, and coordinate the review and management of deviations, CAPAs, change control, and OOS/OOT. The successful candidate will ensure adherence to applicable regulatory requirements and company policies/procedures.

PRIMARY RESPONSIBILITIES: 

  • Manage all required activities to support release of drug substance and drug products including review and approval of master batch records, executed batch record review and Quality assessment of change controls.
  • Provide guidance on the resolution of deviations, discrepancies, testing issues, Out of Specification/ Out of Trend (OOS/OOT), investigations, complaints, and Corrective and Preventive Actions (CAPA) as needed, with advice from management.
  • Notify CMC team and QA Management of potential quality issues.
  • Provide GMP quality assurance expertise during development of Aptose products.
  • Lead and/or assist GMP onsite audits at Contract Manufacturing Organizations (CMOs) and other external vendors as needed. Coordinate with consultants where needed.
  • Ensure all required quality activities are initiated and completed according to the development stage with advice from QA Management.
  • Ensure that drug products are designed, developed, manufactured, and controlled according to adequate quality standards
  • Establish a quality risk management approach in projects and training to ensure that quality is understood and managed by all stakeholders throughout the product life cycle, with advice from management.
  • Participate and represent quality activities in CMC team meetings
  • Assist with the preparation of Quality Agreements in collaboration with CMOs and review contracts in conjunction with the CMC team
  • Write SOPs and Work Instructions (WIs) related to quality processes; review SOPs and WIs related to CMC processes.
  • Pro-actively participate in the optimization of the quality system by proposing new procedures and tools, or modification of existing ones

REQUIRED EDUCATION & WORK EXPERIENCE:

  • Bachelor’s degree in Chemistry, Biology, or other technical/science discipline.
  • At least 3 years of experience in pharmaceutical product development/ quality control/ analytical development/ chemical production or similar operational positions in the pharmaceutical industry
  • At least 3 years of experience in Quality Assurance of drug substance and/or drug product manufacturing and testing
  • Knowledge and understanding of Drug Substance and/or Drug Product development, manufacturing process, quality control, packaging, and distribution
  • Thorough knowledge of cGMPs
  • Ability to interpret and implement Quality standards with advice from management
  • Ability to manage complex projects and prioritize workload according to the project importance
  • Ability to pro-actively initiate and lead quality activities with coaching from management
  • Ability to manage multiple tasks with competing priorities
  • Good interpersonal and influencing skills
  • Self-confident, assertive, and autonomous to deal with complex stakeholders/situations
  • Ability to communicate clearly and professionally both verbally and in writing
  • Provide coaching and advice to others as needed.

FUNCTIONAL / TECHNICAL KNOWLEDGE & SKILLS: 

  • Manage and improve process
  • Problem solving
  • Adaptable to changing priorities and competing demands
  • Teamwork
  • Collaborate
  • Communicate effectively in English, both oral and written
  • Deliver on commitments
  • Maintain composure
  • Proactively plan and organize
  • Be self-aware
  • Detail oriented and meticulous follow through
  • Facilitate
  • Influence and persuade
  • Lead

TRAVEL REQUIREMENTS: 

  • 25%

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Accepted formats: PDF, Word Doc

Accepted formats: PDF, Word Doc