This position reports directly to the Site Quality Head and will serve as the Quality Systems and Standards, Quality Compliance and Product Release Lead for the Site.
Together with their direct reports, the Site QSS, Compliance and Product Release Manager will serve as a partner alongside other stakeholders, to maintain Site and Product Portfolio Quality Compliance, be the Site Owner of the Quality Management System (QMS), responsible for regulatory compliance surveillance and will be responsible for the execution of all quality related governance aspects for Quality (QA and QC) and Operations at the site.
For the QSS part of the role, the Site QSS, Compliance and Product Release Manager reports also dotted line to the Zoetis Global Quality Systems & Standards (QSS) Lead, The Site QSS, Compliance and Product Release Manager will have overall responsibility to assure that the Site is compliant and aligned with Zoetis Global QSS and Zoetis Global Regulatory Surveillance Process.
QSS responsibilities include ensuring Quality System & Standards for the Site are compliant with EU, FDA, USDA or other pertinent regulations. Ensuring Systems, Standard Operating Procedures and Quality Tools are in place and in use as well as being properly maintained in control. Through the Key Quality Performance Indicator Dashboard, they will monitor Site quality systems performance and facilitate appropriate metrics and communications, and drive Quality Continuous Improvement activities through leadership of the Site Quality Council as well as administration of the Site Quality Road Map ultimately ensuring continuous site inspection readiness.
The role also has primary responsibility for Manufacturing and Product release activities in maintaining alignment with Regulatory Compliance and Zoetis Registrations where site’ products are distributed.
The Manager will be responsible for leading a team of associates that have QSS and Regulatory Compliance oversight roles throughout the Site. The Manager will provide coaching/feedback to enhance the group and individual’s professional performance and development. The Manager will also keep succession plans updated to minimize hiring lags as roles become open in the group. The Manager will periodically review the groups’ training record to maintain adequate competency and ensure annual GMP quality training is given at Site.
- Lead the application of the Zoetis Global Quality Standards and Systems and tools at the Site. Maintain the Site QSS in a state of compliance with all applicable Regulations.
- Develop and use effective monitoring and controls for key processes and product quality - providing assurance of continued suitability and capability of processes.
- Through Key Quality Performance Indicator (KPI) Dashboard, monitor Site quality systems performance.
- Administer Site Quality Management System (QMS) governance through management reviews to ensure its continuing suitability and effectiveness.
- Implement a quality risk management process to help monitor and control systems and to identify and prioritize areas for continual improvement of process performance and product quality throughout the product lifecycle.
- Process owner for the Site’s Quality Council.
- Develop, oversee and monitor the Site Quality Plan/Roadmap. (Site Quality Leader is Accountable, QSS Manager is Responsible)
- Monitor Internal and External Factors Impacting the Quality Management System (i.e. emerging regulations, innovations that might impact the Site QMS).
- Lead and oversee Site Quality training plan and establish an appropriate method to check for effectiveness.
- Ensure that the Site Validation Master Plan is In-Place and In-Use.
- Oversee and monitor the Site computer system validation (CSV) plans and execution.
- Provide specific Site Wide data integrity (DI) awareness and training on an annual basis.
- Ensure GMP documentation is properly managed and archived,
- Oversee Site License registration process & Responsible Contact for Site License Registration Process and Management of GMP Certificates to ensure they are kept up to date.
- Ensure that Product release is in compliance with the registration files (QP) and fulfill the role of QP Batch Release Responsibility.
- Assuring Site Regulatory Compliance to Registrations via the Regulatory Change Management process, dossier harmonization and working closely with Global Regulatory Affairs and Veterinary Medicines Research & Development (VMRA/VMRD) colleagues
- Manage the timeliness and effectiveness of the Site completion and use of Annual Product Reviews (APRs).
- Lead the Site internal audit program, proactively identifying improvement opportunities and agreeing/prioritizing improvement actions with Site stakeholders to ensure continuous inspection readiness.
- Lead Site regulatory inspections, preparation for and agreeing to remediation and CAPA plans with Regulatory Agencies.
- Consolidating outcomes and conducting risk assessment of BOH audits, GQCA audits, regulatory letters, site QMS compliance assessment, manufacturing alerts and other relevant documents for the Site and its contractors or suppliers to identify trend and ensure CAPA plan is monitored, implemented, and effective.
- Leading the Site external contract service providers (CSP’s) and suppliers audit program
- Consolidating audit data for tracking/trending for compliance communications to Site and above site respective Leadership Teams
- Approve Laboratory, Manufacturing and Packaging Master Batch Records.
- Final product release
- Ensure deployment and maintenance of compliant, robust, aligned, lean and efficient quality systems and tools at the site, which are aligned with Quality Risk Management Principles and which support GMS and commercial strategy, and support the product lifecycle.
- Assure the use of operational excellence tools in quality procedures and processes and Drive continuous improvement initiatives which positively impact process performance and product quality throughout the product lifecycle and provide assurance of continued suitability and capability of processes through Lean methodology and QRM Principles.
- New Product Introduction – assure that all applicable quality aspects are met to support efficient product release at site
- Develop and support for site budget and resources planning for the above-mentioned functions,
- Immediate notification to the Site Quality Head of any quality issues, and provide accurate and relevant information as required by the business,
- Assure the use of operational excellences tools in quality procedures and processes.
- Serving as a quality culture role model and instill a strong quality and compliance culture across the site. Lead people development and succession plans for the Quality Compliance and Product Release function,
- Support the development of quality goals and targets as part of the organization’s strategic plan
EDUCATION AND EXPERIENCE:
- Undergraduate degree in pharmaceutical, biological, chemical sciences, or engineering.
- Relevant advanced degree preferred
- QP Eligibility desired
- Minimum of 10 years progressive experience in the quality control, quality assurance, manufacturing operations in human or animal health.
- Current knowledge of cGMP’s and demonstrated leadership of Regulatory Inspection Management and Regulatory Affairs.
- Working knowledge/fluency of Quality Management Systems.
- Recognized Lean Six Sigma Qualification (Green Belt or Black belt) desirable
- Working knowledge of ICHQ10 principles
TECHNICAL SKILLS REQUIREMENTS:
- Fluency in quality systems and regulatory compliance.
- Driven / Passionate about Quality performance and delivering results.
- Demonstrated ability in leading / managing people.
- Ability to develop and build a strong leadership team which can support the business
- Sets Clear Direction and Aligns Team and Others Around Common Objectives
- Exercises Good Judgment and Drives Change– using appropriate influence techniques.
- Strong written and oral communication skills
- Drives for Superior Results
- Inspires Continuous Improvement and Breakthrough Thinking, utilizing problem solving tools such as Lean/ Six Sigma
- Ability to manage multiple projects simultaneously and prioritize work, goals and tasks in accordance with division and corporate objectives
- Proficient in English
- Demonstrated written communication skills, as well as experience with presenting to leadership teams.
- Business Fluency and Ability to be a Trusted Partner
- Site based position
- This position will require fluent use of teleconferencing and Webex tools, as well as Sharepoint technologies, to share and manage information
- This position will need to achieve results through colleagues with a direct reporting relationship (QA team) as well as indirectly with Global groups such as GSS; VMRA, and GQCA. Additionally, they will work closely with the Corporate QSS Leader to stay current with all Zoetis QSS and Regulatory Surveillance practices, systems, and strategies.
- The successful candidate will need to interact regularly with leadership at the site, particularly site Quality and Functional Leads, Global Regulatory Affairs and Global Manufacturing Technology (GMT).