Quality Assurance Director
BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Director of Quality Assurance to work for a San Diego Area contract manufacturing company.
Director of Quality Assurance
The Director of Quality Assurance provides leadership and is responsible for establishing and maintaining quality management systems and processes that meet the quality requirements of the company; establish and maintain GXP compliance systems in support of a portfolio of pharmaceutical and device commercial products, which meet applicable regulatory, compendia, and statutory requirements and guidelines; ensure that all QA systems and practices are implemented and followed for internal operations and outsourced work with contractors and third party vendors; manages activities related to product release, stability, validation, adherence to GXPs, vendor audits, change control, document management, and QA training; collaborates with key stakeholders to ensure compliance of development activities with appropriate regulatory requirements, including support for inspections, audits, ANDA, NDA submissions, and dossier approvals.
- Quality System Management Representative
- Chair management review process, documentation and follow-up
- Internal audit function
- cGMP training for all staff & visitors
- Review, investigate and respond to all complaints
- Promote quality achievement and performance improvement throughout the organization and with key vendors.
- Sets QA compliance objectives in alignment with business objectives and ensure that targets are achieved.
- Provide oversight of compliance of third parties to GXPs and established quality agreements.
- Lead development of the company’s QMS in keeping with evolving needs, for compliance to cGMP FDA/EMA/ICH/GXP/ISO requirements and for continued improvement in compliance and operational efficiency.
- Manage QMS document access, new document creation, revisions and necessary training. Ensure documentation is in compliance with global regulatory filings and applicable global regulatory requirements.
- Establish and manage budgets for the unit.
- Define and implement quality system procedures and policies.
- Develop proposals for system and process development or modification to support the company’s mission of continuous improvement.
- Develop/review SOPs/documents to fulfill global development requirements.
- Assist in the establishment of product and material specifications and ensure that product complies with specifications and meets all necessary standards for safety, purity, identity and efficacy.
- Review or oversees the review and approval of deviations and change control to all documents and investigates the results of product and/or process non-conformance.
- Establish a vendor audit plan and ensure timely audits and effective closure of quality issues of supplier and contract organizations providing critical raw materials or performing GXP services.
- Maintenance of CAPA system. Lead or oversee any investigations and ensure the execution and closure of CAPA plans.
- Participate in the review of quality sections of contractor agreements and leads the preparation and approval of QA Agreements and ensure operations and activities are in compliance with such approved agreements and Tesaros QMS.
- Provide detailed project timeline and budget projections related to QA operations in support of the company’s development programs.
- Maintain document control system
- Support the internal transition of paper to electronic files and transfer of legacy documents associated with product license/acquisitions.
- Effectively manage the company’s document and material management system including oversight of off-site storage of active and archived materials.
- Regularly meets with the VP Product Development, Quality & Regulatory affairs, VP Facilities and Manufacturing, to report quality issues and resolutions, review recent results, set next plans, and assure appropriate progress is being made on assigned programs.
- Maintains a clean and safe work environment and follows all safety policies and procedures.
- Other assignments as directed by Supervisor.
- Provide leadership, establishing, and maintaining quality management systems and processes that meet the quality requirements of the company.
- This position has supervisory responsibilities over one or more supervisors and their employee’s in the Quality Assurance department.
Education and/or Experience
Bachelor's degree (B. A.) from four-year College or university; or four to ten years related experience and/or training in Quality Assurance preferred; or equivalent combination of education and experience.
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or boards of directors.
Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to define problems collects data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
To perform this job successfully, an individual must have knowledge of database, spreadsheet and word processing software. The organization uses Microsoft Office (Word, Excel).
Certificates, Licenses, Registrations
- B.S. in Biological Sciences.
- 7-10 years of related experience in pharmaceutical or medical device industry (preferably pharmaceutical).
- Quality Assurance, ISO, Six Sigma, or other Quality Training or Certification.
If interested, please contact Drew Stephens at (562)495-3200 x2 or send him a copy of your most updated resume at email@example.com. Please visit www.biophaseinc.com for additional jobs as well!!