The Manager, Commercial Quality Assurance is responsible for managing quality operations at Adamas commercial service providers of drug substance, drug product, packagers and distribution centers to ensure that Contract Service Providers are in compliance with applicable regulations, Quality Agreement(s), and Standard Operating Procedures (SOP’s).  This role reports to the Senior Manager, Commercial Quality Assurance and is based in Emeryville, CA.

Responsibilities:

  • Develops, establishes and maintains quality assurance programs and systems, policies, processes, procedures and controls to ensure that performance and quality of commercial suppliers conform to established standards and regulatory agency requirements;
  • Responsible for the oversight of master batch record review and approval, executed batch record review, assessment of deviations, change controls and analytical data;
  • Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure continued compliance;
  • Works directly with commercial suppliers to ensure that operations remain in a compliant state, and product meets all required standards and specifications; specifically, managing commercial change control, lot disposition, quality investigations and CAPA closures;
  • Quality oversight responsibilities from validation to commercial scale up;
  • Leads external commercial quality audits, and supports Adamas during CMO site inspections by regulatory agencies;
  • Responsible for Annual Quality Review and supporting regulatory submission;
  • Ability to work collaboratively and independently with commercial and development product manufacturing teams, business partners, CMOs and vendors;
  • Complies with corporate policies and procedures, as well as, US healthcare laws and regulations.

Qualifications:

  • Bachelor’s degree in science or related field and 5 to 7 years of relevant hands on experience in a highly regulated manufacturing environment;
  • In-depth knowledge of QA principles, concepts, industry best practices, regulatory standards, and ICH Guidelines;
  • Experience in of manufacturing, packaging, labelling, and distribution of oral solid dosage drug product intended for commercial distribution;
  • Knowledge of performance measures and Quality Improvement Statistical tools, preferred;
  • Demonstrated ability in exercising superior judgement and working independently with minimal supervision and/or guidance;
  • Effectively adopt systemic approaches to maximize efficiencies and scalability;
  • Ability to manage tasks with competing priorities or deadlines;
  • Ability to understand / implement written and verbal instructions to all levels in the organization;
  • High level of professionalism and collaboration in team, cross functional and sub-teams settings;
  • Ability to travel to vendor sites (up to 40%) depending on business needs;
  • 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 www.dol.gov/ofccp.

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 www.dol.gov/ofccp.

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.