Job Grade: PT11F
Hiring Manager: Liliana Marques
Internal Posting Date: -
Professional | Permanent | Full-time | Hybrid
Our people in Manufacturing & Global Operations share two priorities: getting things done and making things better. If you’re a dynamic person with a positive mindset, you’ll fit in well here. It’s an international team with a powerful spirit of collaboration. Together, we make sure our products meet the highest standards of quality by constantly searching for ways to improve at every stage of our value chain – from the raw materials we buy through to the logistics network that brings our medicines to patients. Join our team and help us make an even bigger contribution to Grünenthal’s future.
What the job looks like:
- Ensure E2E quality oversight of supplier products portfolio and associated supply chains, including project management, ensuring compliance with Good Manufacturing Practices (GMP), regulatory requirements and internal Grünenthal standards.
- Act as interface partner with other global and local strategic departments and business units, such as the Virtual Site Operations Team (VSOT), including External Supply Operations (ESO), Supply Chain, Procurement, Chemistry, Manufacturing, and Controls (CMC), Internal Manufacturing Quality (IMQ), Commercial Quality Assurance (CQA) and other internal stakeholders to support product lifecycle activities and CMO management;
- Ensure that suppliers continue to develop and implement best practices that emphasize prevention and provide for continuous improvements to meet quality standards.
- Overview of the GMP supplier network of the Grünenthal affiliates and/or Grünenthal sites.
- Oversight of the Supplier Performance Management Program. Gain quality oversight by monitoring, reporting and escalating supplier performance results.
- Support Grünenthal global audit program by planning, preparing and conducting audits of external suppliers, including onsite, postal and remote audits.
- Lead Quality oversight of supplier products portfolio and associated supply chains, including project management, ensuring compliance with Good Manufacturing Practices (GMP), regulatory requirements and internal Grünenthal standards. Activities include, but are not limited to:
- Technical Quality Agreements (TQAs): Prepare and maintain Technical Quality Agreements with suppliers, ensuring roles and responsibilities between parties are clearly defined;
- Change management: Ensure that all changes to GMP documents, processes, equipment and facilities are effectively managed through the supplier and Grünenthal change control processes in order to maintain GMP and regulatory compliance;
- Deviation management: Review non-conformances (e.g. process deviations, out of specification/trend results) at supplier to ensure investigations accurately identify root causes, assess potential impact and define appropriate corrective and preventive actions (CAPAs) within acceptable timelines;
- Complaints management: Ensure suppliers conduct proper investigations of complaints and manage product complaints within Grünenthal QMS;
- Batch records: Confirm appropriate level of CMO batch record reviews are conducted at suppliers and within Grünenthal (as necessary);
- Validations and qualifications: Review and approve CMO validation protocols and reports during technical transfers and process change activities as required as per TQA in place;
- Stability: Ensure CMO stability programs are established and implemented by suppliers in compliance with cGMP and regulatory requirements, including regular reporting, trend analysis and investigation of out-of-specification results as needed;
- Product Quality Reviews: Confirm PQRs are completed by suppliers (whenever applicable), trends are identified and corrective/preventive actions are implemented;
- Supplier Performance Tracking: Monitor suppliers performance using KPIs and quality metrics, driving continuous improvement initiatives and supplier development initiatives as needed;
- Audit/Inspection readiness: Assist CMOs in preparing for audits and inspections, and represent Grünenthal during regulatory inspections as needed;
- Quality Visits: Perform visits to suppliers to assess GMP compliance, support resolution of quality issues and engage in discussions on ongoing quality topics and performance improvement;
- Recall: Participate in the review and recall of defective product, as necessary, in order to minimize patient risk.
- Collaborate, whenever applicable, cross-functionally within the Virtual Site Operations Team (VSOT), including External Supply Operations (ESO), Supply Chain, Procurement, Chemistry, Manufacturing, and Controls (CMC), Internal Manufacturing Quality (IMQ), Commercial Quality Assurance (CQA) and other internal stakeholders to support product lifecycle activities and CMO management;
- Contribute to the deployment, maintenance and continuous improvement of the ESQ processes;
- Participation to quality relevant projects and other improvement projects, aligned with ESQ Strategy;
- Participate in issue resolution, supplier development initiatives, quality-oriented business review, business review meetings and S&OP meetings with suppliers.
What you'll bring to the table:
- University degree, preferably in Chemistry, Pharmacy or Engineering and have gained relevant practical experience in production or quality control or quality assurance within pharmaceutical industry.
- At least 4 years broad experience in Pharmaceutical Industry.
- Auditing experience, incl. excellent working knowledge of international GxPs for the manufacture, control and distribution of commercial product and clinical trial materials.
- Extensive knowledge of international authority regulations (e.g., PICs, ICH, and FDA) including applicable ISO norms. Additional knowledge of R+D requirements are of advantage.
- Knowledge of elements and requirements in Pharmaceutical Quality Systems.
- Knowledge of the principles of solid, semi-solid and liquids dosage manufacturing processes (tablets, capsules, gels, creams, ointments), experience with aseptic manufacture would be beneficial.
- Knowledge of QC and Stability chemical analytical testing techniques.
- Familiar with the regulatory requirements for validation activities as applied to manufacturing and packaging processes, analytical methods, cleaning procedures, computerised systems.
- Demonstrate strong understanding of cGMP, regulatory requirements and ICH guidelines.
- Show deep understanding of end-to-end supply chains and proactively assesses the potential impact of quality issues on supply continuity and product availability.
- Exhibit good negotiation and communication skills, with the ability to influence internal and external stakeholders.
- Manage multiple CMOs, projects and priorities independently and effectively within a fast-paced environment.
- Maintain an analytical mindset and critical thinking skills, with attention to detail and problem-solving capabilities.
- Approach conflict and high-pressure situations with calm and organization; demonstrate confidence and openness in international and intercultural teamwork.
- Be willing to travel up to 40% for supplier visits and audits.
- Project Management skills and a well-structured approach of organizing processes. Result-oriented, reliable and discrete.
- Advanced in Quality System Applications and digital tools e.g. SAP, MasterControl, Microsoft Power BI.
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Liliana Marques, the Hiring Manager
