Director Global QC Materials

We are different. We strive for better. Our people never settle for the status quo and as you push the boundaries of your potential, you not only change your life, you change others’ too.

We are looking for people who share our passion, drive, and energy – what we call Genki. Join us as a Director Global Raw Materials in the Global Quality team, and commit your life’s work to impacting where it matters most: human lives.

We are a dynamic global company and our focus is to combine technical leadership in cell culture, microbial fermentation and gene therapies with world class cGMP manufacturing facilities to advance tomorrow’s medicines.

With sites in Hillerod Denmark, Billingham & Wilton UK, North Carolina, Texas and California USA, the size and breadth of our business will open up huge opportunities for you, whether you want to move to a different role in the UK, relocate, or progress and take on more responsibility.

Our teams are proud to partner with innovative companies reimagining what’s possible in biopharmaceuticals. Every day at FDB is a day for improvement, each challenge is an opportunity for growth, and every moment is a chance to evolve together.

Job Purpose
Responsible for driving development and implementing the FDB global QC material strategy, the Director of Global QC Materials will set the direction and execute the strategy according to plan with global FDB stakeholders, to ensure our KojoX strategy. They will ensure continued focus on identification, improvements and implementation of optimizations across FDB Global QC. The Director will continuously work with the management team to make sure that we put people first, and that we have motivated and engaged employees and we ensure we are an employer of choice.

Reporting directly to the VP of Quality Control (Global), this role can have 1-5 direct reports, with the possibility of having 20-50 indirect reports.

Main Activities and Responsibilities:

• Create a common/standard for material documentation requirements, assessments and testing strategy across the Company
• Lead and develop a team responsible for driving, supporting, and improving the way we work with material strategy across FDB to ensure shared material strategy
• Develop and implement the global material strategy to optimize work with our internal and external stakeholders, to support KojoX
• Execute managerial tasks per the Company policies (e.g. Workday, compensation, 1:1 etc.)
• Oversee and responsible for the tech transfer area related to materials in QC (agreement with customers, specs. SJR reports etc.)
• Ensuring compliance on materials regarding customer, vendor and regulatory requirements
• Ensure continued improvement and capacity development via the QC materials network
• Enforce established policies, processes and procedures and identifies areas where enhancements will improve daily work.
• Cross functional collaboration and project team leadership assignments consistent with personal strategic, operational and technical leadership.
• All other duties as assigned.

The Director of QC Materials is accountable for GMP compliance for materials according to USP, EU GMP (part 1 and 2), 21 CFR part 210, 211, 820, 11 and other applicable GMP guidelines. Although with no direct budgetary responsibilities, they will provide input to the overall Global QC budget.

This role has a direct impact on the global strategy for QC materials and responsibility for the performance and quality of QC materials related activities in the tech transfer process. They interact closely with global internal and external stakeholders to ensure alignments are made across teams as part of the shared materials strategy and KojoX vision including level loading of resources where needed. This role will oversee a highly complex team with many responsibilities and stakeholders in many departments and direct relations to customers and vendors.

In collaboration with Global QC management team, you will make decisions regarding:

• Quality issues and complex investigations
• Development and building the Global QC material strategy and organization
• People management and development

Background Requirements and Education:

• Master’s Degree in one of the following areas: Analytical Chemistry, Organic Chemistry, Pharmacy or similar
• + 8 years of experience with analytical testing (preferably raw material testing and release), GMP experience, Drug Product requirements
• + 5 years management experience
• Leadership experience and capabilities
• Strong ability to prioritize work and activities, and give overall direction
• Excellent people management skills
• Coaching skills including meeting every employee on the level needed – adaptable to team members’ style of working
• Project management skills
• Proven ability to plan, prioritize and to complete own work and the work of others
• Proven ability to work in a team and as individual
• Proven ability to work on a global level
• Extensive knowledge within analytical raw material methods (Compendia/non-compendia)
• Extensive understanding of GMP guidelines
• Excellent verbal and written communication skills in English (excellent communication skills in Danish is desired).

At FDB, your passion, your Genki is your power and we empower you to define what Genki means to you.

When you join us, we will train, develop and support you to become the best you can possibly be.

This is a global position that will support all our FDB sites. This position can be based at any of our locations around the globe. Benefits and compensation will be governed by the location that you are based from and considered your home site.

As part of any recruitment process, FUJIFILM Diosynth Biotechnologies collects and processes personal data relating to job applicants. The organisation is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations and may share this as part of the global recruitment process with hiring managers in Europe and the United States.

Application
Interested candidates are invited to submit their resume and cover letter detailing their qualifications and experience as soon as possible and no later than the 24th of September 2024.

For any questions about the role, please contact VP Global QC, Marlene Asklund at [email protected]

Working at FUJIFILM Diosynth Biotechnologies

FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication, and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.

We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.

We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.

FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Location: FDBD Hillerod