Head of Corporate QMS

Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) employing over 5,200 employees worldwide. Recipharm provides manufacturing services of pharmaceuticals in various dosage forms, including, sterile fill & finish, oral solid dosage and biologics; clinical trial material development and manufacturing services; and, pharmaceutical product development. Its biologics segment, ReciBioPharm, works with customers to develop and commercialise advanced therapy medicinal products (ATMPs): pre-clinical to clinical and commercial development and manufacture for new biological modalities, encompassing technologies based on live viruses and viral vectors, live-microbial biopharmaceutical products, nucleic acid-based mRNA and plasmid DNA production.

Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. It operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden and the US and is headquartered in Stockholm, Sweden. For more information on Recipharm and our services, please visit www.recipharm.com and www.recibiopharm.com

Ihre Aufgaben

Reporting to the Head of Quality Management, the Head of Corporate QMS will be responsible for leading the development, implementation and maintenance of quality processes and procedures; acquisition, analysis, and interpretation of quality data; and the making of recommendations for improvement of important processes throughout the organization.

The mission of the Coporate QMS team is to lead supplier qualification audits, conduct corporate quality audits and govern operational quality performance and regulatory compliance of Recipharm manufacturing sites.

The successful candidate will execute the Quality strategy including digitalization roadmap with Site Quality Directors and ensure successful achievement of defined objectives.,

• Participate in the development of corporate strategy providing functional leadership and challenge to test the viability of the strategy and contributing creative ideas and insights to support the strategy formation process.

• Anticipate and mitigate regulatory and compliance risks of sites. Ensure and support the progress of the Quality Roadmap and achievement of the defined objectives and anticipate local challenges. Ensure the strategy is successfully implemented and meets medium-term business needs.

• Foster and support compliance and efficiency improvements with the sites. Capture best practices and lessons learned to standardize process improvements across the network.

• Prepare annual plans of quality assurance assessments and ensure they are successfully implemented. Involves working in a complex environment and in accordance with business or operational plans.

• Ensure that business activities within a significant area of responsibility comply with relevant external regulatory and internal policies and procedures.

• Lead Compliance risk assessment and propose risk mitigation plan to minimize business risks and protect the reputation of the organization.

• Guide and support the diligent management of escalations.

• Responsibility for the operation performance of German sites (Cuxhaven, Monheim, Zwickau)

• Manage and report the quality performance and compliance of assigned sites, as well as the execution of defined strategic goals. Set appropriate performance objectives for direct reports and hold them accountable for achieving these; take appropriate corrective action where necessary to ensure the achievement of annual business objectives.

• Co-design, implement, maintain, improve and oversee the Quality Management System across all sites.

Ihr Profil

• Master's Degree or equivalent level

• Minimum of 10 years' experience providing expert competence and interpreting strategy and policy in order to set and deliver objectives within medium to long term timeframes

• Experience in the CDMO/Pharmaceutical industry

• Operational Quality experience

• Strong analytical and problem-solving skills

• Excellent communication and interpersonal skills

• Fluency in English

  DESIRABLE

• Fluency in German

• Experience in aspectic manufacturing

• Auditor qualification

  WHAT WE OFFER

  Our core values of Respect, Reliability, Collaboration and Excellence shape every aspect of our work and our interactions with all our stakeholders. We seek individuals who are respectful, considerate and honest, value diversity and show integrity in their daily work. Our culture thrives on reliability, ensuring we consistently deliver on our promises and meet the expectations of our stakeholders through operational excellence. We believe in the power of collaboration, fostering an agile environment through teamwork and active listening. Our relentless pursuit of excellence drives us to deliver high-quality products and services, while maintaining a supportive and inclusive atmosphere where every team member is recognised and valued. Join us to be part of a community that is committed to mutual success and high standards.

Kontakt

URL to this pagehttps://www.recipharm.com/careers/job-search/apply?rmpage=job&rmjob=3399&rmlang=UK