• Job Description

  Req#: JR2799
  FUJIFILM Diosynth Biotechnologies in Hillerød is seeking a highly skilled and dedicated PQA Lead to join our dynamic team. This role plays a crucial part in our expansive growth, focusing on our expansion projects.

  If you have a passion for quality assurance and an in-depth understanding of pharmaceutical engineering, we encourage you to apply.

  About the Role

  • Support the Head of PQA in overseeing expansion projects.

  • Lead in ensuring project quality aspects, operational and audit readiness.

  • Contribute to Project Quality Risk identification and resolution, advising on Project Quality plans.

  • Serve as the quality point-person for PQA team and project team direction.

  • Implement and guide actions towards audit readiness and compliance, particularly for mock- and DKMA audits.

  Professional Qualifications

  • Master of Science in Pharmacy, Chemistry, Biotechnology, or a related field.

  • Solid understanding and extensive experience in GMP and quality within large-scale biotechnology projects.

  • Expertise in Quality and Compliance issues.

  • Proven track record in GMP audit execution and management.

  • Strong experience in collaborating with other departments and Project Managers/Leads.

  • Demonstrated experience in supervising and ensuring timely delivery of Quality Engineering project deliverables.

  • Extensive biotech experience, including design and construction of biopharmaceutical manufacturing facilities.

  • Proficient in operational and audit readiness, with a knack for managing complex projects in active facilities.

  • Exceptional coordination, planning, leadership, and communication skills.

  • Ability to maintain work pace, meet deadlines, and adapt to changing business needs.

  • Proficient in MS Office Suite (Excel, Word, Visio, and Project).

  Personal Qualifications

  • Hands-on, motivated, and accurate with a proactive quality mindset.

  • Ability to communicate effectively at all levels within the organization.

  • Strong leadership and problem-solving abilities, aiming for the overall success of projects.

  • Team player with a focus on flexibility and adaptability.

  Your application
  Has this sparked your interest? Then we urge you to apply as soon as possible.

  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.

  Our site in Hillerød, Denmark, brings together expertise, capabilities and technologies to manufacture advanced biologics. The large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill finish to the site.

  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. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.

  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.

• About the company

  A global CDMO in pharmaceutical manufacturing providing process development and cGMP production in cell culture, microbial fermentation and gene therapies.

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