Senior Manager, Quality Assurance

Location
Redwood City, CA
Posted
Oct 06, 2021
Ref
4117770004
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract

Senior Manager, Quality Assurance

Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory, and proliferative diseases.

Allakos is committed to developing innovative therapies that transform patients’ lives.  We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.

Position Summary:

As a member of the Allakos team you will be responsible for activities pertaining to external vendor audits, internal audits, and quality agreements.

Your Role:

  • In collaboration with QA team, establish the annual audit plan
  • Schedule and prepare GxP audits
  • Perform GxP audits of manufacturing, packaging, labelling, testing, storage, and distribution quality systems for drug substance and drug product in accordance with the company procedures
  • Assess vendor status based on regulatory and GxP requirements
  • Support vendor risk assessment
  • Initiate corrective and preventative actions as a result of observed audit deficiencies
  • Communicate observations with potential risk and product impact to stakeholders
  • Participate in executive management review
  • Establish and review Quality Agreements
  • Review and update GMP related SOPs and policies

 

Qualifications and Expertise

  • At least 6 years of relevant experience in the area of quality assurance in the Biotech/Life Sciences arena
  • Bachelor's degree or higher
  • Significant Auditing experience
  • Experience working with Contract Manufacturing Organizations
  • Working knowledge of cGMPs (US and EU)
  • Excellent communication skills, both oral and written.
  • Excellent interpersonal skills, collaborative approach essential.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
  • Self-motivated with a strong sense of ownership in areas of responsibility.

The salary is competitive and commensurate with experience and qualifications.

The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership

Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.