Manager / Sr. Manager, Quality Assurance
San Diego, CA
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.
- 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.
- 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 email@example.com.