Department: Quality Assurance (QA)
CEL-SCI is seeking an experienced individual for a high-level management position within the Quality Assurance (QA) Department to help lead the Company through the commercial launch of its new immunotherapeutic drug product. This is a complex biological drug product produced by aseptic processing.
A critical component of the FDA drug approval process is the successful completion of a Pre-Approval Inspection (PAI) of its drug Manufacturing facility and its Quality Control testing laboratories. A proven track record in this process is required. This is a hands-on position that reports to the Vice President QA
As the Director of Quality Assurance you will have the opportunity to work in support of our quality systems covering our Manufacturing facility and Quality Control laboratories. You will be responsible for providing QA support for Deviation and CAPA investigations and evaluation of risk management to assure compliance with domestic and international regulatory and industry standards.
To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:
Education & Experience:
- BS in Life Sciences (preferably biological life sciences). Advanced degree preferred
- Minimum of 10 years direct QA experience in all aspects of Biopharmaceutical Quality Assurance (Manufacturing, Quality Control, Validations, Environmental Monitoring etc.)
- Must have had direct hands-on experience, in a leadership role managing CGMP inspections from various regulatory agencies (FDA, EMA, etc.). This experience should include acting as the “escort” to the inspectors during their inspection
- Must be able to train others throughout the Company in proper inspection practices relative to interactions with the regulatory inspection team
- Must have experience in Aseptic Filling of injectable drug products
- Thorough knowledge of US and EU CGMP regulations
- Excellent interpersonal skills to motivate, direct and manage a group of 10 -15 QADC and QA Audit staff working shift schedules.
- Ensure compliance with applicable CGMP regulations.
- Be inspection ready at all times
- Support and provide leadership in the overall planning and execution of Validation activities
- Other duties as assigned
Skills & Abilities:
- Excellent oral and written communication skills for effectively interfacing with internal and external organizations
- Strong initiative and project management skills
- Must have excellent attention to detail and time management skills as well as the ability to manage multiple priorities with aggressive timelines and changing priorities
- MS Word and Spreadsheet capabilities (PC based)
- Write, review, revise, approve GMP documents (batch records, SOPs, Specifications, Protocols etc.)
- Perform Internal and external CGMP Audits (vendor qualifications)
- Able to manage and bring to close GMP: Deviations, OOS investigations, CAPA investigations etc.
- Able to manage multiple projects simultaneously
- Able to lift and carry 30 lbs.
- Ability to and experience in proper gowning for entering Clean Rooms (ISO 5 – 8/ EU Grade A, B, C, D)
- Excellent communication skills (oral and written)
- Able to develop and present CGMP training programs
- Release final drug product for use.
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 . 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.