Manager, Quality Assurance

Location
Emeryville, CA, United States
Posted
Jul 13, 2021
Ref
1117
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
COMPANY DESCRIPTION:

Santen is a specialized pharmaceutical company with a 130-year heritage focused exclusively on ophthalmology. With sales in over 60 countries, Santen’s 4,000 global employees work to deliver life-changing therapies that make hope a reality for people facing vision impairment and loss. Santen Inc., located in Emeryville, CA (North America HQ), contributes important research & development and commercialization efforts. This office is home to about half of our 300-total staff in North America, including our Toronto, Canada site and our recent acquisitions of Eyevance Pharmaceuticals (Fort Worth, TX) and InnFocus (Miami, FL).

We are in search of top talent to help us meet our important goals and large growth plans.
ABOUT THE POSITION:

The Manager, Quality Assurance is responsible for supporting GMP Quality Assurance at Santen Inc. located in Emeryville, CA and Eyevance Pharmaceuticals in Fort Worth, TX. Responsibilities include internal and external audits, preparing Annual Product Reviews, and Quality Agreements, release of product, developing and approving SOPs, management of third party manufacturing, packaging, and distribution, planning, leading and supporting investigations, complaints, change controls, and CAPAs, and management of quality systems.
ESSENTIAL DUTIES AND KEY DELIVERABLES:
  • Performs a wide variety of activities to ensure compliance of drug product with GMPs. and applicable regulatory requirements.
  • Supports development and approval of specifications, test methods, SOPs, and master batch records.
  • Develops, implements, and maintains compliant GMP Quality Management Systems,
  • Supports timely release and distribution of products from outsourced manufacturing, testing, and distribution operations.
  • Supports Good Distribution Practice requirements for distribution of commercial products.
  • Partners with supply chain, Product Development, External Manufacturing Service, Supply Chain and Commercial teams to commercialize new products.
  • Partners closely with External Manufacturing Services to manage third party contractors.
  • Develops and communicates key messages to CMOs through business review meetings.
  • Develops Key Performance Indicators, metrics, and prepares Quality Management Reports
  • Works with key stakeholders and CMOs to ensure timely closure of investigations, complaints, and change controls.
  • Works with CMOs and key internal stakeholders to ensure Santen Inc. and Eyevance Pharmaceuticals and their respective outsourced partners are prepared for regulatory inspections.
  • Leads/supports internal audits of Santen Inc. and Eyevance Pharmaceuticals and external audits of contract laboratories, CMOs, distribution centers, and suppliers as required.
  • Supports resolution of quality or compliance issues that require an in-depth knowledge of operational and regulatory requirements.
  • Informs leadership of quality or compliance issues that could have major impact to the company and provide leadership with options for mitigation.
QUALIFICATIONS:

  • Minimum B.S. B.A or equivalent in a scientific discipline or equivalent experience in pharmaceutical quality.
  • 5-7+ years of experience in a quality assurance function with prior people management experience.
  • Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.
  • Demonstrates in-depth knowledge of U. S. regulatory requirements (GMP, GDP, etc.).
  • Demonstrates excellent verbal, written and interpersonal communication skills.
  • Demonstrates understanding of Computer Systems Validation and ICH Guidelines.
  • Demonstrates knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement.
  • Demonstrates working knowledge of Risk Management tools HACCP or FMEA.
  • Able to read and understand technical forms and manufacturing data.
  • Able to manage multiple products simultaneously.
  • Able to develop and maintain strong working relationships.
  • Strong organizational and analytical skills.
  • Must be goal oriented and quality focused.
  • Can handle conflicts by quickly finding common ground and get cross functional cooperation to achieve resolution.
  • Experience with commercial and sterile products.
  • Advanced skills in Microsoft Word and Excel.
  • Knowledge of ophthalmology is desired but not required.
  • Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations is desired but not required.