Customer Program Quality Manager

Your New Role

We work with various biopharma companies, which means each project we work on brings a unique set of tasks. You will be the link between our customers and our FLBD team and expected to operate with a high level of independence and professional judgment in a complex stakeholder landscape.

You will be involved in all quality related topics related to both Commercial and Tech Transfer programs making sure customers are informed and involved in the quality work related to their program. You will interact with highly skilled personnel to support your communication on complex activities. We continuously strive to identify opportunities to improve systems and practices and to ensure the strong collaboration between FUJIFILM operational teams and our customers.

You represent our company: our mission of advancing tomorrow’s medicine, our passion for collaborating with our partners for life, and our dedication to seeing every project through with the highest amount of integrity and impact.

Main Responsibilities

• Be the primary point of contact to customers regarding quality related topics both during commercial and Tech Transfer processes.
• Drive discussions with customers to support ongoing activities for example on deviations, changes, CAPAs, complaints.
• Be a link between customer and internal organization; preparing upcoming communication with customers on specific quality topics.
• Support revision of existing Quality Agreements.
• Support manufacturing activities including representing quality assurance in the core team for the program.
• Prepare and participate in customer visits and audits.
• Establish, develop and maintain department documents: customer presentations, SOPs and participate in our internal Continuous Improvement activities.
• Ad hoc tasks.

Skills & Knowledge, we hope you possess

The candidate holds a Master’s degree in Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences or similar with interest and knowledge of GMP and quality systems with a minimum of 10-year relevant QA experience.

The perfect candidate has experience operating in the field between internal processes/organization and facing the collaboration with the external customers.

You are service minded with excellent verbal and oral communication skills. Fluency in English is required as English is our corporate language.

This role demands that you facilitate operational elements in the actual program execution. It requires a personality that induce sufficient business acumen and process insight to drive, facilitate, and manage stakeholders across the entire business with authority and charisma.

We hope you are

• Positive and organized with an attention to detail and still able to keep an overview in a changing environment.
• Your mindset is team oriented and collaborative.

Your New Team & Department

The Program Quality Management (MFG) team consists of 9 highly skilled and dedicated team members with broad experience within pharmaceutical manufacturing. The team is an organization embedded in the Quality Assurance organization with links to a global PQM group and provides quality support to production of engineering, clinical, PPQ and commercial batches in large scale Drug Substance manufacturing, filling of Drug Product and Assembly, Label and Pack.

The work environment is international and informal. We keep a high pace and focus on a vital life balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.

Your Application

Does this sound interesting? Then please upload your CV and cover letter as soon as possible, as we will continuously invite relevant candidates for job interviews. The job advertisement will be removed when the right candidate has been identified.

In case you have any questions, please do not hesitate to contact Head of Program Quality Management, Manufacturing, Annelise Olsen +45 41945471.