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. 


  • 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. 


  • 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. 



Apply for this Job

* Required


U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at Adamas Pharmaceuticals are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.