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Director of Quality / Vacaville, California

Employer
Polaris Pharmaceuticals, Inc
Location
Vacaville, CA
Start date
Jul 18, 2022

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Job Details

Role Title                      Director of Quality

Department                Quality  

Supervisor                  Sr. VP of Operations    

FLSA                           Exempt

 

CORE VALUES 

 

Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration

 

FUNCTION SUMMARY      Quality Director

The Director of Quality is responsible for leading the Quality Team in maintaining all aspects of quality within a highly collaborative and cross-functional environment ensuring product quality, compliance, and customer satisfaction for both in-house and CDMO products. The Director of Quality manages the Quality Assurance and Quality Control departments and is responsible for the following functions: release and stability testing; method validation; environmental monitoring program; CMC-related regulatory activities; raw material quarantine, inspection, sampling, testing, and release; lot release; deviations and CAPA; supplier management and internal audit programs; document and change control programs; training program; facility and utility quarantine and release; complaints and product returns; and drug product shipping. This individual will need to build systems/processes and organize resources to establish and achieve product release cycle time targets and meet project due dates/deliverables. Additionally, the Director of Quality will be responsible for establishing a scalable quality system to support the future growth of a multi-product GMP manufacturing facility, including PAI preparation and implementation of computerized quality systems.

Duties & Responsibilities:

  1. Ensuring Polaris quality requirements are compliant with the appropriate regulations by various regulatory bodies/entities.
  2. Approve or reject drug products for clinical and/or commercial distribution.
  3. Approve or reject all procedures, specifications, validations, and changes impacting the regulatory commitments for Polaris products.
  4. Provide guidance and overall business strategy to QA & QC personnel in maintaining the quality functions to support the master production schedule.
  5. Partner with the Production and Facility departments to create and maintain the site Master Validation Plan.
  6. Provide development opportunities for reporting staff and maintain overall training methodologies for all quality associates.
  7. Responsible for hosting audits of Polaris by regulatory authorities, qualified persons, clients, and partners. Support audits and investigations, reviewing/approval technical content to ensure scientific merit & compliance to regulations.
  8. Ensure the Polaris external audit and internal audit programs meet current business strategies and objectives.
  9. Management of raw material introduction, review, and release system for all materials used in drug manufacturing.
  10. Responsible for the leadership of quality control functions including cGMP analytical method development, testing, validation, and routine QC laboratory operations.
  11. Management of the product review and release system. Management of Change Control and Document Control Systems. Keep up to date of current Quality Standards and Regulations impacting the biopharmaceutical industry. Responsible for organizing Quality Management Review and compiling and reporting on the performance of the quality system.
  12. Develop and recommend quality system improvements to support future business strategies.
  13. Oversee the development and maintenance of the stability program.  Review stability data and stability reports, providing guidance where needed.
  14. Oversee investigations for “systemic” quality events at the site, including resolution strategies, CAPA implementation, and Material Review Board decisions.
  15. Provide leadership with respect to sample scheduling and daily process prioritization. Holds self and others responsible to abide by department and company policies and practices. Implement system improvements and procedural revisions, with emphasis on increasing laboratory efficiency, accuracy, and safety. Attend all department meetings, support discussions and formulation of ideas for laboratory infrastructure improvements and method optimization. Perform trend analysis/reports and critical thinking to the progression of the environmental monitoring programs, method validation, investigations, technical studies, and method transfer protocols. Oversee site-related CMC activities. Final sign-off on all product labels, package inserts and Marketing Material.
  16. Determine the financial needs of the Quality departments to create and manage an annual budget that is consistent with strategic direction, division needs, and stakeholder expectations.

Skills & Competencies

  • Ability to manage complex projects involving multiple functions
  • Ability to gain consensus on key quality/operational decisions Strong analysis/problem solving skills
  • Strong attention to detail/quality focus Balanced cost/quality/customer focus
  • Ability and willingness to provide leadership to the entire group, with proficiency in both facilitating active and open discussion, and laying groundwork for logical decision making. Ability and willingness to collaborate with and influence other groups in a positive, team-based environment.
  • Must also be able to hold others to account as required.
  • Work with a sense of urgency and have the ability to be impartial and objective.
  • Excellent communication skills, (both written and verbal), excellent interpersonal and presentation skills and be team focused.
  • Excellent organizational skills.
  • Be an active learner and developer of self and others.
  • In-depth knowledge of International Standards, GLP, and GMP Experience with GMP, analytical, and environmental monitoring/analysis preferred. Experience in hosting and leading FDA and other regulatory authority audits, would be an advantage.
  • Experience in developing and delivering effective training on Quality Systems and Processes is preferred.

Education & Experience

  • B. S./B. A. in Science/Related Field (major in biology-biochemistry-chemistry). 8-12 years of relevant management experience in a biopharmaceutical quality field is desired. MS Degree in Science/Related Field (major in biology-biochemistry-chemistry). 5-9 years of relevant management experience in a biopharmaceutical quality field is desired. PhD in Science/Related Field (major in biology-biochemistry-chemistry). 3-6 years of relevant management experience in a biopharmaceutical quality field is desired.

Company

Polaris Group is a multinational biotechnology company focused on developing novel anti-cancer therapies. Our lead drug candidate, Pegargiminase (ADI‑PEG 20), is a biologic in late-stage clinical development for a wide range of cancers, including hepatocellular carcinoma, mesothelioma, pancreatic cancer, non-small cell lung cancer, melanoma, acute myeloid leukemia and others. Polaris Group is involved in every stage of the drug development process. Our family of companies harnesses structure-based drug design technology to create novel oncology therapies, conducts clinical studies at top-tier cancer centers worldwide and operates cGMP Production Facilities in Northern California and China

Polaris Group's Strategic Partner Nanotein Technologies Launches GROW-NK, a Revolutionary NK Cell Activation and Expansion Reagent, Propelling the Field of NK Cell Therapy

Stock Exchange: Taiwan

Stock Symbol: 6550.TDW
 

Company info
Website
Phone
707-451-0441
Location
4941 Allison Parkway, Suite B
Vacaville
CA
95688
United States

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