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This position reports directly to the Site Quality Lead and will serve as the Quality Compliance and Product Release Manager for the Site. Together with their direct reports, they will serve as a partner alongside other stakeholders, to maintain Site and Product Portfolio Compliance.
The Compliance and Product Release Manager will be the system owner for the internal audit programand Regulatory Inspection Management and have overall responsibility, working closely with the Quality Systems and Standards Manager, to ensure continuous site inspection readiness.
The role will be responsible for Regulatory Compliance Surveillance for the Site QMS.
The role also has primary responsibility for Manufacturing and Product release activities in ensuring that the product continues to meet it’s regulatory obligations (510(k)) and site registration and listing
The Manager will be responsible for leading a team of associates that have Quality and 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.
Key objectives of this position include:
- Oversee Site License registration process.
- Perform Laboratory, Manufacturing and Packaging executed Batch Record reviews
- Ensure that Product release is in compliance with the registration files
- 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.
- 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, 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.
- Write and Review and/or Approve GMP procedures related to supplier qualification and quality agreements,
- 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
- Responsible Contact for Site License Registration Process
- Ensure MDR’s and vigilance reporting's are filed in the allowable timeframes.
- 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.
- Monitor Internal and External Factors Impacting the Medical Device/In Vitro Diagnostics (i.e. emerging regulations, innovations that might enhance the medical device quality system)
- New Product Introduction – assure that all applicable quality aspects are met
- Develop and support for site budget and resources planning for the above mentioned functions,
- Immediate notification to the Site Quality Lead of any quality issues, and provide accurate and relevant information as required by the business.
- 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.
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. 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).
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 medical device and in vitro diagnostics.
- Current knowledge of cGMP’s and demonstrated leadership of Regulatory Inspection Management and Regulatory Affairs specific to medical devices and in vitro diagnostics.
- Recognised Lean Six Sigma Qualification (Green Belt or Black belt) desirable
- Working knowledge of 21 CFR Part 820, ISO 13485 and ISO 14971key principles.
TECHNICAL SKILLS and COMPETENCIES REQUIRED
- Fluency in quality systems and regulatory compliance.
- 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
- Strong written and oral communication skills
- Drives for Superior Results
- Inspires Continuous Improvement and Breakthrough Thinking – utilizing problem solving tools such as Lean and 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 Awareness & Continuity
PHYSICAL POSITION REQUIREMENTS
- Union City, California Site based position
- This position will require fluent use of teleconferencing and Webex tools, as well as Sharepoint technologies, to share and manage information