Secura Bio Careers

Manager / Sr. Manager, Quality Assurance

San Diego, CA

Job Description

Secura Bio is a pharmaceutical company with approved oncology therapeutics in the United States and in other global markets.

The Manager/Sr. Manager, Quality Assurance will be a key contributor to Secura Bio’s cGMP quality systems. Responsibilities include vendor qualification and oversight; cGMP training; lot release; deviations investigation and CAPA programs; documentation authorship, review and management. The position will report to the Vice President, Manufacturing, Regulatory & Quality.

Key Responsibilities Include:

  • Plan and coordinate implementation of a system of procedures and records for cGMP operations.
  • Establish a vendor qualification program, conduct or monitor audits and questionnaires and maintain periodic requalification schedules.
  • Implement a document storage and maintenance system for all cGMP documentation, in compliance with current regulations.
  • Update the personnel cGMP training program, record keeping and maintenance and periodic refreshers.
  • Provide quality oversight to vendors and partners, actively interacting with them.
  • Perform internal audits (self-inspections) to ensure adequate compliance with regulations and approved submissions and dossiers.
  • Coordinate and support audits internally and with vendors as well as corporate partners.
  • Initiate and/or review change control for cGMP documents, follow up on progress plans and ensure timely completion and closure.
  • Lead quality investigations for customer complaints, deviations, CAPA, and NCMRs related to internal processes or at contract vendors.
  • Provide input and review to labeling materials to ensure contents and format agree with quality standards.
  • Lead the batch record review and lot release process for commercial and clinical products.
  • Review CMC sections of regulatory submissions.
  • Prepare Annual Product Reviews by collecting internal and partner information about each commercial product.
  • Establish and maintain metrics related to cGMP activities, present to management, and participate in process improvement.
  • Take the lead and coordinate audit response efforts for health authority or regulatory inspections.

Required Experience:

  • Bachelor’s degree in a Life Sciences discipline or equivalent experience required.
  • Minimum five (5) years of relevant experience in pharmaceutical and/or biotech regulatory affairs disciplines.
  • Minimum of three (3) years of functional leadership experience.
  • Thorough knowledge of cGMP regulations and good documentation practices.
  • Prior experience with contract manufacturing organizations.
  • Detail oriented with strong written and verbal communication skills.
  • Proven ability to lead and manage projects and teams.
  • Experience interacting with suppliers, regulators, and senior staff.
  • Strong organizational and analytical skills.
  • Must have excellent customer service attitude.
  • Ability to work independently and in collaboration with internal and external teams.
  • Ability to develop, recommend and implement procedures.
  • Aptitude and motivation to learn and assume new responsibilities.

Desired Experience:

  • Experience working in a start-up environment.
  • Strong MS Office and presentation skills.
  • Supervisory experience a plus.
  • Experience with Electronic Documentation Management Systems (EDMS) is a plus

Secura Bio offers competitive compensation and generous benefits.

If you meet the requirements for this position, please email us at careers@securabio.com.