The Director of Quality Operations at Vibalogics will primarily be responsible for supporting late phase and commercial quality operations’ activities. This highly motivated member of the Quality Unit will promote a culture of compliance throughout the organization through providing quality oversight of raw material disposition, manufacturing quality oversight, batch documentation review and batch disposition. This Quality team member will be integral in building systems to support Quality Operations and in leading critical cross-functional collaboration.
Reporting to the Head of Quality and Regulatory the Director will be accountable for building and managing the quality operations team, in raw material release, product batch record review, deviation investigation/review, complaint investigation/review, lot disposition, and the review of process validation protocols/reports.
Quality Operations specialists and Product Disposition specialists
- Establishing and managing the Quality Operations Systems at Boxborough, MA
- Develop and manage systems for control, handling, and disposition of raw materials
- The disposition of drug substance and drug product to cGMP
- Identify and initiate improvements to the Quality Operations Systems, ensuring compliance to all relevant quality standards and regulatory requirements
- Work with clients, to establish and then comply with quality agreements
- Receiving, investigating and responding to Product Complaints
Essential job functions
- Timely review and disposition of CGMP manufacturing batches, through a consistent risk based process
- Communication directly with the quality contacts within the client’s organization
- Coordinate and support the creation of and revisions to Standard Operating Procedures (SOPs) within Quality Operations
- Collect and report of quality operations metrics via Quality Management Reviews and the Quality Council
- Promote a Quality Culture
- Build and manage QA Systems staff and processes that will drive innovation, teamwork and efficiency within the organization
- Ensure effective investigations and establish corrective and preventive actions to the adhered timelines to prevent recurrence
- Ensures the company is in a constant state of inspection readiness across all functions through continuous education, training and internal audits.
- This role may require travel, including internationally, up to 25%
- Ability to define problems, collect data, establish facts, and draw valid conclusions
- Adaptability and Flexibility – The ability to adapt as the role and company develops from the systems creation to the routine execution.
- Communication and Teamwork – Ability to effectively express ideas in written and oral context; to work co-operatively with others.
- Concern for impact – Specifically in the communication and explanation of quality decisions/recommendations to external stakeholders.
- Organizational Skills – Ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness
- Detail-oriented and highly motivated with excellent written and verbal communication skills required
Knowledge, skills and experience
- BS degree in life sciences, chemistry or related field with a minimum of 10 years of experience in Biotech or Pharma and 5+ years’ experience in Quality management roles including making product disposition decisions
- Knowledge of how to identify key quality metrics for driving a compliance culture
- Ability to effectively prioritize and manage multiple projects and tasks
- Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based decisions
- A team player, who listens effectively and invites response and discussion
- A collaborator who communicates in an open, clear, complete, timely and consistent manner, with stakeholders and critically with customers
- Ability to oversee projects to deliver high-quality work product to meet deadlines, cost, and quality goals
- Extensive knowledge of ICH Q7, Annex 1 and Sterile Drug Product Guidance
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.