Head of CMC Compliance - Global

Head of CMC Compliance - GlobalAre you ready to ensure global regulatory compliance and drive operational excellence across a complex, multinational organization?Do you have a passion for leading cross-functional teams and building regulatory strategies for blockbuster innovative products?Are you excited about leading global organisations?Fraser Dove International is partnering exclusively with a leading pharmaceutical organisation. Operating globally, they are committed to ensuring regulatory compliance and driving Innovation.Our client is seeking a strategic leader to oversee Global CMC Compliance.Discover more about our Head of CMC Compliance opportunity; its objectives, duties/responsibilities, and the skills, experience, and competencies needed to succeed.Your objectives:As the Head of CMC Compliance, you will be measured against the following objectives:Ensure regulatory compliance of all medicinal products and medical devices with applicable guidelines, regulations, and approved authorizations.Develop and implement strategic initiatives to enhance global CMC compliance and drive continuous improvement across all quality processes.Lead and develop a global team, fostering a culture of continuous improvement and operational excellence.What you will do:As the Head of CMC Compliance, your duties and responsibilities will include:· Ensuring regulatory compliance for all medicinal products and medical devices, in line with guidelines, regulations, and approved authorizations.· Managing the change control process and ensuring timely and efficient creation of regulatory documentation for dossiers.· Determining CMC-regulatory strategy and ensuring QA oversight over due diligence and post-merger integrations.· Supporting the preparation of GMP documents, such as PQRs, technical agreements, manufacturing instructions, and validation protocols.· Recruiting, coaching, and developing the Global CMC Compliance team, while managing resources and supporting career development.· Planning and monitoring the budget for Global CMC Compliance.· Supporting cross-departmental projects focused on operational excellence and business development.· Assisting the Head of Global Quality Assurance with strategic definition and planning, as well as leading special projects.What you will bring:These are the skills and experience you will need to succeed as the Head of CMC Compliance:· Strong leadership skills, including feedback capabilities to motivate and develop a diverse, global team.· A global and service-oriented mindset with a strong sense of cultural diversity.· The ability to prioritize and manage multiple complex projects, ensuring critical deadlines are met.· Experience in continuous improvement and process excellence, with a focus on driving efficiency gains.· University degree, preferably in Pharmacy, with several years of experience in Quality Assurance, Regulatory Compliance, and/or Regulatory Affairs in pharmaceutical companies.· Profound knowledge of CMC dossiers, regulatory requirements, and quality documentation for medicinal products.· Several years of experience leading and developing teams of approximately 20 people across different time zones and cultures.· Expertise in process improvement, with experience using OPEX, Kaizen, LEAN, and other continuous improvement tools.· Fluent in German and English.Got what it takes?To apply for the Head of CMC Compliance, click the ‘Apply’ button below or contact the Executive Search Consultant – Aidan Russell – on +44 (0)203 355 7050.Please Note:· This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments.· If you have not heard from an Executive Search Consultant within ten working days from the date of your application, please consider yourself unsuccessful on this occasion.· We use the information in your application to support your job search, contact you with relevant opportunities, and to improve our services. For more information on how we process your personal data, please view our Privacy Policy available on our website: https://www.fraserdove.com/privacy-policy/Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture, and distribute life-changing drugs, treatments, and devices which transform and save patient lives.