Director of Quality Assurance

Biovire•Brighton, MI

About The Position

General Description The Director of Quality Assurance is responsible for the oversight of all assurance related activities related to the manufacture, testing, and release of drug products. The Director of Quality Assurance is responsible for departmental SOPs, Policies, and Procedures related to the assurance and compliance of Good Manufacturing Practices (GMP's). The Director of Quality Assurance is a member of the Quality team and oversees Quality Operations and Sterility Assurance functions. DUTIES AND RESPONSIBILITIES The Director of Quality Assurance will report to the VP of Quality and lead teams across Quality Operations and Sterility Assurance, ensuring alignment with site quality objectives, regulatory expectations, and operational priorities. Essential Duties and Responsibilities: 1. Oversees Quality Operations and Sterility Assurance functions, ensuring alignment with site quality objectives 2. Oversees Deviation, Change Control, and CAPA management systems 3. Oversee customer communication for Quality Assurance customer related issues/initiatives 4. Maintain effective and compliant sterility assurance program that adheres to federal, regulatory, industry, and customer standards 5. Provides specific Quality Assurance input, guidance, decisions, and actions related to Quality Systems and Standard Operating Procedures 6. Approves SOPs, protocols, Change Control, Deviations, Validation / Test Methods, Policies, and other documents as appropriate 7. Provides leadership and support on regulatory, customer, and 3rd party audits as needed. 8. Advisor to the operations management team on QA issues/initiatives (e.g. problem solving, identification and escalation of significant QA issues). 9. Point of contact for quality-related issues, ensuring timely escalation and resolution. 10. Confirms compliance of site personnel with sterile manufacturing regulations and internal procedures. 11. Develops area of responsibility as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance, and data integrity 12. Support Annual Product Reviews 13. Develop department specific goals and metrics based on the key business metrics and department responsibilities 14. Leadership development a. Mentoring and developing b. Annual goal setting c. Annual reviews Behavioral Expectations: 1. Strong work ethic and ability to accomplish tasks without supervision, 2. Exhibits leadership, both by work and example, 3. Strong organizational skills and the ability to focus on multiple projects in a fast-paced work environment, 4. Excellent skills with the ability to communicate effectively interpersonal, 5. Basic computer skills (proficient in Microsoft Office applications), 6. Excellent communication skills, both written and verbal, 7. Possess honesty and integrity with a commitment to the highest legal and ethical standards, 8. Treats every person with courtesy and respect, 9. Knowledge of CGMP and regulatory principles, 10. Commitment to quality in the manufacturing process, 11. Ability to independently analyze and resolve complex issues, 12. Strong sense of initiative, accountability, and responsibility WORK EXPERIENCE AND education requirements Bachelors' Degree, preferably in Life Sciences, chemistry, or related relevant degree. 5+ years of experience in GxP pharmaceutical manufacturing operations 5+ years of experience in a quality assurance role · Demonstrated knowledge and understanding of CGMP with a focus on ISO14644 and USP 1116. Cross functional collaboration QA and QC experience in pharmaceutical industry with environmental monitoring & cleanliness zones is desired Proven track record and practical experience with cGMP requirements Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections. Employment at Bryllan (Biovire) is contingent upon a successful Background check.

Requirements

Strong work ethic and ability to accomplish tasks without supervision
Exhibits leadership, both by work and example
Strong organizational skills and the ability to focus on multiple projects in a fast-paced work environment
Excellent skills with the ability to communicate effectively interpersonal
Basic computer skills (proficient in Microsoft Office applications)
Excellent communication skills, both written and verbal
Possess honesty and integrity with a commitment to the highest legal and ethical standards
Treats every person with courtesy and respect
Knowledge of CGMP and regulatory principles
Commitment to quality in the manufacturing process
Ability to independently analyze and resolve complex issues
Strong sense of initiative, accountability, and responsibility
Bachelors' Degree, preferably in Life Sciences, chemistry, or related relevant degree.
5+ years of experience in GxP pharmaceutical manufacturing operations
5+ years of experience in a quality assurance role
Demonstrated knowledge and understanding of CGMP with a focus on ISO14644 and USP 1116.
Proven track record and practical experience with cGMP requirements
Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.
Employment at Bryllan (Biovire) is contingent upon a successful Background check.

Nice To Haves

Cross functional collaboration QA and QC experience in pharmaceutical industry with environmental monitoring & cleanliness zones is desired

Responsibilities

Oversees Quality Operations and Sterility Assurance functions, ensuring alignment with site quality objectives
Oversees Deviation, Change Control, and CAPA management systems
Oversee customer communication for Quality Assurance customer related issues/initiatives
Maintain effective and compliant sterility assurance program that adheres to federal, regulatory, industry, and customer standards
Provides specific Quality Assurance input, guidance, decisions, and actions related to Quality Systems and Standard Operating Procedures
Approves SOPs, protocols, Change Control, Deviations, Validation / Test Methods, Policies, and other documents as appropriate
Provides leadership and support on regulatory, customer, and 3rd party audits as needed.
Advisor to the operations management team on QA issues/initiatives (e.g. problem solving, identification and escalation of significant QA issues).
Point of contact for quality-related issues, ensuring timely escalation and resolution.
Confirms compliance of site personnel with sterile manufacturing regulations and internal procedures.
Develops area of responsibility as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance, and data integrity
Support Annual Product Reviews
Develop department specific goals and metrics based on the key business metrics and department responsibilities
Leadership development a. Mentoring and developing b. Annual goal setting c. Annual reviews