Quality Assurance QA Manager Contractor

Location
Emeryville, CA, United States
Posted
Jul 12, 2021
Ref
1106
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract
This position is a long-term (12+ month) contract position.


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.

PRIMARY PURPOSE OF POSITION:

This position is responsible for GMP Quality Assurance at Santen Inc. Responsibilities would include support of key quality systems (clinical and commercial), product release, developing and reporting metrics, annual product reviews, auditing, regulatory inspections, and ensuring Santen Inc. and third-party contractors comply with global and U.S. regulations and standards.

MAJOR DUTIES OF POSITION:
  • Performs batch record reviews and timely release of clinical and commercial products and timely release of clinical and commercial products.
  • Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
  • Develops and maintains compliant GMP Quality Management Systems, programs, policies, specifications, methods, and procedures to ensure product quality conforms to established standards and agency guidelines.
  • Work cross functionally and with CMOs to ensure timely closure Quality records including Deviations, CAPAs, Complaints, and Change Controls.
  • Partners with Supply Chain, Product Development, External Manufacturing Service, and Commercial teams to commercialize Santen products.
  • Develops internal and external Key Performance Indicators, metrics, key messages, and prepares Quality Management Reports.
  • Partners with CMOs and key internal stakeholders to ensure Santen Inc. and its CMOs are prepared for pre-approval and routine regulatory inspections.
  • Performs internal and external supplier and contractor audits as needed.
  • Interfaces with regulatory agencies as required.
  • Manages or leads QA personnel, including organizing and prioritizing group tasks, performing training, and writing performance reviews as required.
  • Systems used: Veeva Vault QualityDocs (Document Control); TrackWise (Deviations)


KNOWLEDGE AND SKILL REQUIREMENTS:
  • Minimum B.S. degree is required. Scientific discipline is preferred.
  • 5 years experience in a quality assurance function.
  • Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards along with U.S regulatory requirements.
  • Demonstrates excellent verbal, written and interpersonal communication skills.
  • Strong computer experience and proficiency with Microsoft Office (Word, Excel, PowerPoint).
  • Must be goal oriented and quality focused.
  • Can resolve conflicts by quickly finding common ground and getting cross functional cooperation to achieve resolution.
  • Ability to multi-task and shift priorities quickly.
  • Good organizational skills.
  • Knowledge of drug product manufacturing and Quality components.