A globally leading pharmaceutical company are looking for a Site Product Release Lead to join their API Manufacturing site on a permanent basis. This position reports directly to the Site Quality Leader and will serve as the Product Release Manager for the Site. Together with their direct reports, they will serve as a partner alongside other stakeholders, to maintain Site Product Portfolio Release.
The Product Release Lead will be the system owner for Batch Release and Annual Product Reviews and have overall responsibility, working closely with the Quality Systems and Standards Lead, to ensure continuous site inspection readiness.
- Oversee Site License registration process.
- Approve Laboratory, Manufacturing and Packaging Master Batch Records.
- 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 colleagues
- Manage the timeliness and effectiveness of the Site completion and use of Annual Product Reviews (APRs).
- Support the Site internal audit program, proactively identifying improvement opportunities and agreeing/prioritizing improvement actions with Site stakeholders to ensure continuous inspection readiness.
- Support Site regulatory inspections, preparation for and agreeing to remediation and CAPA plans with Regulatory Agencies.
- Responsible Contact for Site License Registration Process and Management of GMP Certificates
- Assuring Site Regulatory Compliance to Registrations via the Regulatory Change Management process and execution of Lead Site Regulatory Role (compliance Network Member)
- Work with the site QSS Lead to Design, deploy and maintain 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
- 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,
- Serving as a quality culture role model and instil a strong quality and compliance culture across the site. Lead people development and succession plans for the Product Release function,
- Support the development of quality goals and targets as part of the organisation's strategic plan
- Provide coaching/feedback to enhance the group and individual's professional performance and development, keeping succession plans updated to minimize hiring lags as roles become open in the group.
- Periodic review of the groups' training record to maintain adequate competency.
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.
- Recognised Lean Six Sigma Qualification (Green Belt or Black belt) desirable
- Working knowledge of ICHQ10 key principles
Technical Skills and Competencies
- 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
To learn more, apply online or contact Anita Osibuamhe with your CV at to arrange a confidential discussion.