Manager of Quality Assurance
Manager of Quality Assurance
Department: Quality Assurance
The Manager of Quality Assurance is responsible for managing the established CEL-SCI’s internal and external audit program by performing internal audits of current Good Manufacturing Practices (cGMP) processes and documentation supporting the manufacture and testing of a biopharmaceutical drug as well as perform external audits of suppliers and vendors of materials and services. The Manager of Quality Assurance reports directly to the Vice President of Quality Assurance.
Education & Experience:
- Bachelor’s degree in life sciences, preferably biology or chemistry, or equivalent work experience
- 5+ years’ experience in a cGMP Quality Assurance role in the pharmaceutical, biotechnology or biopharmaceutical industry
- 3+ years supervising a Quality Assurance department
Skills & Abilities:
- Strong understanding of current Good Manufacturing Practices (21 CFR Parts 210 & 211)
- Strong understanding of current EU Regulations – Annex 13 and related
- Ability to perform internal and external vendor/service provider audits as required (overnight travel may be required)
- Master Control electronic Quality Management System software experience a plus
- Batch record review, deviation investigations out of specification results, and CAPA investigations
- Ability to gown for Clean Room activities
- Gowning experience in ISO 5, 6, 7 & 8 classified cleanrooms
- Strong computer skills, including use of all components of Microsoft Office (Word, Excel, Outlook, Access, etc.)
- Ability to prepare technical/complex written materials that are accurate, clear, logical, well organized, and grammatically sound
Responsibilities include, but are not limited to:
- Review, approval and release of raw materials for use in cGMP manufacturing and testing
- Perform line/room clearances
- Assist in product label preparation
- Participate as QA floor representative during manufacturing operations
- Managing the internal audits on suppliers/vendors
- Managing the established internal audit program
- Initiation, tracking and closure of Deviations, Change Controls, CAPAs and Out of Specification events
- When appropriate, assist in FDA inspections regarding regulated activities
- Responsible for managing the external audits on suppliers/vendors
- Responsible for managing the established external audit program
- Stay current with CFR and/or FDA guidance documents and EU regulations to ensure that compliance policies are up to date
- Present cGMP training programs to CEL-SCI employees
- Review and approve all cGMP (equipment, inventory etc.) logbooks
- Review and approve executed cGMP documentation and other documents relating to cGMP activities
- Initiate new SOPs and/or revise existing SOPs as needed
- Supervise Quality Assurance staff
- Monitor work habits and attendance of Quality Assurance staff
- Review and approve timesheets and leave requests
- Organize and chair departmental staff meetings
- Prepare and distribute weekly department schedule
- Perform annual reviews of Quality Assurance staff
Position is full time.
Monday through Friday with occasional Saturday work required. Normal business hours are 8:00 AM to 5:00 PM. Occasional weekend and evening work will be required.
Elkridge, MD. Travel between two CEL-SCI facilities (North Baltimore and Elkridge, Md.) will be required.
We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options.
Please submit cv/resume and cover letter to email@example.com. Reference the job title in the subject line of the email
CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.