About the Opportunity
The Qualified Person provides direct support and compliance oversight to internal and external customers. He/ she provides expert input during the development, review, and approval of cGMP documentation and ensures adherence to regulatory and company requirements. Additionally in this position as Qualified Person you will be responsible for the release of intermediates and EU QP certification of products to the Market.
Biologic External Supply Quality (BES Q)
Is the quality unit responsible for GxP oversight of Contract Manufacturing Organizations (CMOs) and business partners involved in the manufacture, testing and transport of Sanofi products.
BES Q staff interact with functional units within Specialty Care Quality (SCQ), Sanofi sites, and other organizations within the Biologic network (e.g. procurement, supply chain, finance) to ensure compliance with internal and regulatory requirements, and to disposition intermediate (e.g. API, drug substance) and finished products with minimal risk to quality or product supply.
- BES Q has responsibility for CMO and CLO activities related to products treating Rare Diseases and Rare Blood Disorders, Multiple Sclerosis (MS), cancer and diabetes
- BES Q is based in Waltham, MA Frankfurt Germany, Haverhill, UK and Ghent, Belgium
- BES Q personnel may be located on-site at CMOs acting as a Person-in-Plant
Specific activities and responsibilities include:
• Selects, develops, and motivates qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills
• Provides leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance
• Coach and mentor staff in all aspect of their job performance and career development including training, feedback, rewards and disciplinary action
• Develop work plans, assign tasks, and supervise team(s)
• Ensure staff has appropriate knowledge of department processes and procedures
• May provide input into the department budget
• Establish and report applicable department or organizational metrics
• Accountable for project completions and achievement of compliance goals
• Represent department in meetings
• Interact with project teams and cross-functional groups
• Address and/or escalate compliance problems and issues to department/organizational management
• Lead and facilitate meetings/workshops
Core responsibilities as Qualified Person
• Responsible for the release of intermediates and the EU QP certification of products to market, or release for export in compliance with the applicable laws, cGMPs and in accordance with the requirements of the marketing authorization
• Check that batch manufacturing records comply with registered details and EU GMP standards
• Review of batch manufacturing records and other documentation associated with QC release in conjunction with Contract Manufacturing Quality Specialists
• Act as a point of contact for queries relating to QP certification and batch release
• Act as point of contact for (local) authorities and during authority inspections
• Ensure that all processes and procedures that are required for QP certification are fit for purpose and in compliance with applicable regulations
• Key interface towards the contract manufacturing organization sites worldwide manufacturing drug products as well as active pharmaceutical ingredients
• Core team member for the execution of global and local Quality Agreements (QAgs) ensuring compliance with all legal/contractual obligations
• Guarantees compliance with current GMPs regulatory and corporate requirements for all regulated activities within scope
• Supports identification, assessment, control and communication of risks involving components, raw materials, finished pharmaceuticals, and medical devices within scope of responsibility
• Ensures the deviation and change control activities are consistently and timely managed
• Ensures implementation and evaluation of corrective and preventive actions to address systemic issues
• Supports organization of an audit management program of CMOs within scope as well as audit program execution in cooperation with global audit program and Supplier Management Operations (SMO)
• Ensures the accurate, timely, and GMP compliant management of technical product complaints from the global market manufactured by CMOs in the scope of responsibility
• Supports the implementation of self-evaluation and continuous improvement tools
• Fosters a strong mindset of Quality culture across the ESQA organization
• Performing audits of CMOs and suppliers as well as self-inspections including planning, organization, performing, reporting and follow-up in cooperation with other functions
To excel in this role, you will need to have:
- Master’s degree in a Pharmaceutical Sciences with option of Industrial Pharmacy
- Minimum of 7 years of relevant work experience in Quality in Pharma
- Minimum of 3 years of experience as a QP in Belgium, experience in Biologics is as advantage
- Ability to produce written and oral communications with clarity and accuracy
- Fluent English in writing and verbally
What Sanofi can offer you
- A generous package including flexible benefits
- A healthy work-life balance throughout your career with us
At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers.
Empower Life Everyday
At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.
Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we’re not there to try to solve everybody’s problems. We want to focus on those areas where we know we are making a difference.
The values we live by are teamwork, courage, respect and integrity.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.