The Director of Quality Control provides leadership and scientific and technical expertise for all QC activities. These activities include the timely in-process and release testing of microbiome and plasmid products, qualification/validation of analytical methods, and the translation of methods from clients and/or Analytical Development (AD) to the cGMP QC testing laboratory. The Director is also responsible for maintaining cGMP compliance in his/her areas of responsibility and for operating within project and department budgets. The Director will work closely with all departments and the appropriate project teams to assist in project planning and timeline development. The incumbent will plan, implement, and coordinate the improvement of QC services, considering the application of up-to-date technical, GMP and quality principles and ensuring safe environmental and working conditions in the QC Laboratories. The Director attracts, facilitates, participates in client projects and maintains good relations and communications with clients as a primary technical interface for QC between the client’s technical staff.
Quality Control managers/supervisors, and Analytical scientists
- Establishing and managing the Quality Control operations at Boxborough, MA
- Manage analytical method transfer and method validation activities
- Establishing and maintaining a stability program for all client products
- The testing of drug substance and drug product to cGMP
- Identify and initiate improvements to the Quality Control Systems, ensuring compliance to all relevant quality standards and regulatory requirements
Essential job functions
- Manages team of managers and professionals within QC. Hires and develops employees within the department. Assigns work, provides feedback and coaching, and takes necessary disciplinary actions.
- Develops appropriate operating and capital expense budgets and strives to have the QC organization contribute to COGS improvement.
- Serves as primary QC contact for regulatory inspections and client audits.
Provide technical leadership of method qualification and validation from AD and/or clients.
- Establish and maintain a robust, timely stability program for clients, as a profit center for the company.
- Support establishment and/or enhancement of QC and operational metrics.
- Sponsor, lead, and/or support establishment of electronic LIMS systems for site.
- Analyzes regulatory authorities’ programs, guidance documents and activities in areas relevant to testing of biological products and advises site and Quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.
- Evaluates the functional strengths and developmental areas in the QC organization and focuses on continuous improvement.
- Coordinate and support the creation of and revisions to Standard Operating Procedures (SOPs) within Quality Control
- Collect and report of quality control metrics via Quality Management Reviews and the Quality Council
- Promote a Quality Culture
- Ability to define problems, collect data, establish facts, and draw valid conclusions
- Interpersonal skills and Teamwork – Ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy
- Organizational Skills – Ability to prioritize and manage through complex processes/projects
- Detail-orientation – excellent written and verbal communication skills required.
- Conceptual Thinking – Must be able to analyze and interpret business periodicals, common scientific, professional and technical journals, governmental regulations and legal documents
- Outstanding leadership abilities with demonstrated analytical and critical thinking skills, combined with team management abilities to establish and maintain high-functioning teams
- Excellent troubleshooting skills with the ability to solve complex problems
- Visionary leadership skills and the ability to interact with all levels
- Proven leader, delegator and decision maker
- Strong financial acumen
- Executive presence with strong interpersonal and communication skills, verbal and written
- Ability to travel up to 10%
Knowledge, skills and experience
- BS required, MS preferred in a scientific/technical discipline with 15+ years of experience in a QC position within the biological and/or pharmaceutical industry.
- 10+ years in a management/leadership role(s)
- PhD in a scientific/technical discipline a plus.
- Extensive experience in microbiological methods and contamination control
- Subject matter experiment in method qualification and validation
- Ability to apply GMP regulations and international guidelines to all aspects of the position
- Ability to write reports, business correspondence and procedure manuals
- Exceptional oral and written communication skills to all organization levels as well as clients and vendors
- Experience with regulatory inspections and client audits
- Experience in both startup/early phase and commercial QC laboratories
- Extensive experience with writing and managing investigations and risk assessments
- Ability to write reports, business correspondence and SOPs
- Very proficient in MS Office application suite as well GMP electronic applications such as LIMS
This role is based in Boxborough, MA
Vibalogics US, Inc. offers a very competitive benefits package including medical, dental, vision, prescription drug coverage, life and disability insurance, 401(k), and generous vacation and time off policies among other attractive benefits. We operate in a world class facility to attract the best and brightest talent to work collaboratively in our mission to bring novel therapies to the patients who need them most.
Vibalogics, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age status as a qualified individual with a disability, protected veteran status, or any other characteristic protected by law.