The Sr. Director, Quality is responsible for all aspects quality assurance, GxP compliance, and Quality Control of Adamas products. The Sr. Director, Quality will establish quality plans and policies and report to Management on a regular basis on compliance activities and findings. This position will design, implement and maintain QA, QC and compliance programs and infrastructure including a SOP system, training program, and perform internal and external audits. The Sr. Director, Quality will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in a GxP international regulatory environment. This position will serve as an in-house advisor on GxP compliance and report to the Vice President, Regulatory, Quality, and Pharmacovigilance. The position is based in Emeryville, CA. 

Responsibilities:

  • Responsible for all aspects of Quality including Quality Systems management and Quality Control activities, owner of the GxP vendor qualification and oversight process; 
  • Development and implementation of the Adamas Annual Product Review / Product Quality Review; 
  • Management of the product complaint system and interaction with the contracted complaint vendor;  
  • Responsible for the GxP compliance auditing program to fulfil regulatory requirements; 
  • Responsible for the management of Pharmaceutical Quality Systems & Continuous Improvement
  • Develop and implement the GMP risk profile process & mitigation through the Quality Planning Process;  
  • Management of the product recall/market withdrawal process; 
  • Responsible for the management of Pharmaceutical Quality Systems & Continuous Improvement; 
  • Provide expertise and guidance to collaborating departments in interpreting and implementing governmental and agency guidelines to assure compliance; 
  • Provide GxP Quality Assurance oversight of vendors and maintain quality agreements; 
  • Interact and develop relationships with vendor’s quality leaders through audits, project teams, and established one-on-one relationships; 
  • Follow applicable regulations, including FDA, ICH, GXP, and Adamas policies and procedures; 
  • Develops organizational structure, ensures that employees are trained and the functional capabilities within the department keep pace with advances in technology and company growth;
  • Fosters talent management, including performance and succession planning, to support the company’s business objectives;
  • Manages the Quality System and make final decisions regarding, disposition status, deviations, investigations, CAPAs, Specifications, expiry and stability as required;
  • Ensures compliance with corporate policies and procedures, as well as, US healthcare laws and regulations. 

Qualifications:

  • Minimum BS, Master's degree or PhD with focus in Chemistry, Life sciences, Engineering or similar technical field; 
  • 15+ (BS), 10+ (MS), 8+ (PhD) years of relevant and current work experience in pharmaceutical industry Quality Assurance and Quality Control required; 
  • Expert knowledge of manufacturing, clinical, and analytical services employed in the Pharma industry; 
  • Solid and demonstrable knowledge of international GMP regulations and guidelines, industry practices, and experience implementing Quality Systems in a regulated environment; 
  • Working knowledge of GLP and GCP international regulations; 
  • Leadership in GxP vendor management and oversight; 
  • Proven background in auditing / audit management, internal, vendor and regulatory; 
  • Knowledge of risk management, mitigation, and controls; 
  • Experience with complaint management; 
  • Strong organization and time management skills; 
  • Attention to detail with an ability to perform critical review of various types of documents; 
  • Excellent communication skills, both oral and written; Presents well in internal meetings and external forums. Able to write clearly and succinctly in a variety of communication setting with minimal editing by others; 
  • Ability to lead and influence peers, superiors, and subordinates; 
  • Demonstrated ability to work as a team player with multi-disciplinary project teams; 
  • Proficiency with commonly used word processing, database systems, document management, and other software; 
  • Successful experience in fast-paced entrepreneurial environment; 
  • Fit with Adamas culture and values. 

 

 

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