Senior Director of Quality
Senior Director of Quality
USDA/Pharmaceutical facility located near Augusta, Maine.
The Senior Quality Director in Maine is responsible for the entire site in Maine- both QA and QC -quality function, ensuring programs and processes are in place to ensure compliance with Global Quality Standards, relevant regulatory authority expectations, and internal/external animal welfare regulations for vaccine production.
While reporting to the Executive Director of Quality located at HQ, the Site Quality Leader (Sr. Director of Quality) partners closely with the Site Head and other functional leaders to ensure all decisions and actions are determined through the application of good science, risk management, and the most current regulatory expectations. As part of the Site Leadership Team, the Site Quality Leader (Senior Director of Quality) acts as a business owner to ensure that overall site goals are met and aligned with corporate goals.
The Senior Quality Director will support and drive improvements across the entire life-cycle of products, including process design, change control, deviations, batch release, stability, complaint management, and performance data review.
Senior Director of Quality Functions, Duties, Tasks:
- Ensures safety of QA and QC personnel through training, policies and systems development, and interface between QA/QC staff and the Safety Department.
- Operate as a member of the Site Lead Team on local initiatives and business plans, both within Quality and across the operation. This includes leading the site Quality Lead Team.
- Manages Quality Control Laboratories to provide a technically sound and timely QC testing function
- Partner with Company Regulatory resources to establish and maintain compliance to 9CFR Vaccine manufacturing requirements as well as Company Global Quality requirements to ensure Manufacturing & Product licenses are maintained (the right to operate)
- Develop and ensure standardization of processes and approaches with the broader Network of USDA registered manufacturing facilities.
- Ensure the Quality Assurance team provides front line operational support as active members of process teams.
- Develop the organization to improve technical depth and capabilities related to US Vaccine manufacturing. This includes identifying individuals with technical and/or leadership potential for succession planning, or recruiting talent as needed.Plans and sets objectives for QA and QC departments; evaluates quality department as a whole to ensure that all required knowledge and skills are available within the function.
- Through the partnership of the Site Lead Team, drive continuous improvement through development and execution of a robust Quality Plan.
- Ensure Periodic Quality Reviews & Periodic Product Reviews are conducted
- Provide oversight of investigations to resolve issues that may impact on the quality of manufactured product and ensure long term preventative solutions are implemented
- Lead Product Recall activity on-site, as needed, ensuring compliance with both regulatory requirements and the requirements of the Quality Manual.
- Ensure compliance of all activities performed by 3rd Parties or suppliers (i.e. Audit adherence; Quality Agreements), as required by applicable internal Standards and Regulatory authorities
- Measure & monitor, in collaboration with other functions on-site, cGMP activities to ensure Manufacturing & Product licenses are maintained (the right to operate)
- Develop talent to sustain local & network competitiveness. This includes identifying individuals with leadership potential, providing mentoring and enrichment opportunities consistent with succession planning.
- Communicate period updates on the quality compliance status of the site.
- Collaborate with Quality leaders within the Vaccines Network to embed the Vaccines network strategy at the site.
- Lead Product Recall activity on-site, as needed, ensuring compliance with both regulatory requirements and the requirements of the Company Quality Manual.
- Ensure robust root cause investigations are conducted with appropriate CAPAs to resolve issues that may impact the quality and/or regulatory compliance of manufactured product
- Participate in the site leadership team and ensure that quality platform is embedded across the site
- Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies.
- Perform any other duties or serve in such other capacity as may be determined by Company management.
Senior Director of Quality - Minimum Qualification:
- Bachelor of Science degree in Science (Biology, Biochemistry, Chemistry, Engineering, Microbiology).
- 10 years’ experience in animal health or pharmaceutical
- Masters or PhD degree in science field is preferred
- Knowledge of Continuous Improvement Six Sigma and Lean Principles
- Demonstrated experience in the pharmaceutical or vaccine industry
- Experience in Quality Operations, Manufacturing and/or other relevant operational areas, but must include Quality, managerial or project management experience.
- Thorough knowledge of relevant vaccine manufacturing regulatory requirements.
- Strong understanding of regulatory requirements for commercial global Vaccine processes
- Demonstrated learning agility
- Proven track record with inspection management FDA, USDA, EMEA, and others
- Strong understanding of risk assessment and risk management fundamentals/tools
- Technical understanding of Vaccine manufacturing/testing processes
- Fluent in speaking / writing English
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