Senior Manager, Quality Assurance

Location
Emeryville, CA, United States
Posted
Sep 11, 2018
Ref
ojbk8fwG
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
COMPANY DESCRIPTION

Santen is a specialized pharmaceutical company focused exclusively on ophthalmology in global markets around the world with more than 3,500 employees and sales in approximately 60 countries. Santen Inc., located in Emeryville, CA, contributes important ophthalmic research and development efforts worldwide and is home to our regional business teams. This office currently employs about 140 people and will grow by 50%+ in the near future.

With the passionate support of our Japanese parent company and its 125-year heritage, Santen is pursuing intellectually-challenging and stimulating work to deliver game-changing therapies that make hope a reality for people facing vision impairment and loss.

We are driven by and committed to our mission: Delivering Vision, Every Day. Additionally, our Corporate Strategy Policy for FY18-FY20 has provided essential focus for new commercialization efforts that will be fueled through an unprecedented increase in marketing investment and talent acquisition across Marketing, Sales, and R&D teams.

We are in search of top talent to help us meet our aggressive and important goals

PRIMARY PURPOSE OF POSITION:

This position is the primary lead for GMP systems and functions at Santen Inc. Responsibilities include planning, developing, and implementing quality systems to support commercial and clinical activities and ensuring third party and Santen Inc. operations comply with global and U.S. regulations and are in an inspection ready status. This position supports global quality and system initiatives.

MAJOR DUTIES OF POSITION:
  • Manages QA personnel, including organizing and prioritizing group tasks, performing training, and writing performance reviews.
  • Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
  • Develops/maintains compliant GXP Quality Management Systems, programs, policies, specifications methods and procedures
  • Ensures product quality conforms to established standards and agency guidelines and support timely release of commercial and clinical products across internal and CMO operations.
  • Develop and support metrics, communications and business review presentations for CMOs.
  • Leads or coordinates internal and external compliance audits as required. Ensures audits are conducted on a continuing basis to ensure quality of outsourced manufacturing.
  • Interacts with contract manufacturers to address documentation and compliance issues.
  • Ensures compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
  • Work in cross-functional teams as needed to lead site to a state of regulatory compliance.
  • Support resolution of quality or compliance issues that require an in-depth knowledge of operational and regulatory requirements.
  • Inform leadership of quality or compliance issues that could have major impact to the company and provide leadership with options for mitigation.

KNOWLEDGE AND SKILL REQUIREMENTS:
  • Minimum B.S. degree in a scientific discipline is required.
  • Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.
  • Demonstrates in-depth knowledge of U. S. regulatory requirements (GMP, GLP, 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.
  • Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations.
  • Must be goal oriented and quality focused.
  • Can handle conflicts by quickly finding common ground and get cross functional cooperation to achieve resolution.
  • 8+ years of experience in a quality assurance function with prior people management experience.
  • Experience with commercial products, sterile products and medical devices is mandatory.
  • Knowledge of ophthalmology is a plus.


WORK ENVIRONMENT and ENVIRONMENTAL CONDITIONS:

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

E