Sr. Manager Change Control – Quality Systems
Santa Monica, CA
A commercial biopharmaceutical company is hiring full time Quality Assurance professionals in greater Los Angeles. Having recently achieved our first approved therapy, we are seeking to
Enhance our quality management system with automated features.
The Change Control QMS professional will provide oversight and manage changes to computerized corporate Quality Systems.
This position will perform as leader in the Quality Engineering department by ensuring changes are planned, authorized, implemented and tested in compliance with all applicable procedures.
Change Control QMS professional will support QMS / quality system – and business owners in assessment of regulatory and quality risks posed by proposed changes, ensure accuracy and completeness of system inventories, change records, supporting documentation and procedures. The Change Control professional will interface and build strong partnerships with IT, Engineering, Manufacturing, R&D and other parts of the Quality organization.
- Participate in – and manage change control meetings.
- Oversee change implementation and documentation.
- Ensure change control conformance to regulations and quality policies.
- Manage the change control system workflow and ensure maintenance and approval of related documents.
- Supportregulatory inspections and audits as a subject matter expert for the Quality Management System.
- Establish and manage risk assessment process for system changes.
- Support vendor qualification and compliance audits.
- Review technical/investigation reports as appropriate.
- Review and approve proposed changes to systems and procedures.
- Track, review and report metric information for use in continuous improvement of areas of responsibility.
Required Skills and Qualifications:
- Quality Assurance, Regulatory Compliance, GMPs, Health Authority Regulations and Computer System Validation practices/principles: 21 CFR Part 11.
- Excellent analytical skills and strong knowledge of GMP, SOPs and quality systems.
- Identifying, writing, evaluating and closing changes and experience with internal and external audit principals.
- Familiarity with aseptic manufacturing processes.
- Strong knowledge of change control practices/strategies.
- Computer System Validation – 21 CFR Part 11.
- Proficient in MS Word, Excel, Power Point and other applications.
- Strong written and verbal communication skills. Ability to communicate and work independently with scientific/technical personnel.
- Minimum of 8years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product).
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, ICH 10).
- Minimum of 3 years of management experience.
- Bachelor’s degree in technical discipline (Computer Science/Engineering or similar).
- Experience in the medical and/or pharmaceutical industry.
- ASQ, Black Belt/Green Belt certifications.
Relocation assistance is available.