Associate Manager, Compliance Support – End-to-End (Cell culture through purification) Manufacturing

FLBD FUJIFILM Life Sciences Biotechnologies Denmark ApS; Hillerød; Vor Ort; DKK 850.000 - 1.150.000; Vollzeit

Benefits dieser Stelle

Fitness facilities

Canteen

Zusammenfassung

FUJIFILM Biotechnologies Denmark in Hillerød, Denmark, seeks an Associate Manager to lead the Compliance Support Team for a single end-to-end API line (cell culture through purification). You will drive deviation handling, root cause analysis, CAPAs, and audit readiness while collaborating with Manufacturing, QA, MSAT, Engineering and Planning.

You will manage 6–12 Investigators, establish priorities, ensure timely investigations, and maintain cGMP compliance with a safety-first culture.

Qualifikationen

• Proven people-management experience in GMP manufacturing or quality/compliance roles.
• Strong track record in deviation management, root cause analysis, CAPA, and risk assessment.
• Operational excellence mindset; experience with LEAN, flow optimization, and visual planning is a strong advantage.
• Solid knowledge of cGMP, data integrity, and documentation standards within pharma/biotech.
• Experience interfacing with API production and both cell culture and purification operations is a strong plus.

Aufgaben

• Lead, coach, and develop a high-performing team of Investigators.
• Set direction and priorities, manage workload, and ensure motivation and accountability.
• Own daily/weekly planning, triage, and queue management to meet end-to-end lead time targets.
• Ensure high-quality investigations, robust root cause analysis, effective CAPAs, and strong deviation documentation across USP and DSP.
• Drive standard work, visual management, and performance metrics (cycle time, aging, RFT).
• Optimize handovers and escalation paths with Manufacturing and QA to secure flow across unit operations.
• Build audit readiness through housekeeping, data integrity, and compliance rigor.
• Promote cross-training and capability building to enhance flexibility across USP/DSP.
• Challenge status quo and implement LEAN/continuous improvements end-to-end.
• Communicate changes, risks, and decisions clearly; follow through and close actions.
• Deliver on time per internal/customer agreements while maintaining cGMP compliance and a safety-first culture.

Kenntnisse

People management

GMP

Deviation management

Root cause analysis

CAPA

LEAN

Data integrity

cGMP

Cross-functional collaboration

English communication

Danish language

Jobbeschreibung

Are you a people manager eager to join a fast-growing pharmaceutical company? We have a unique opportunity for an Associate Manager who shares our passion, drive, and energy – what we call Genki – to lead our Compliance Support Team across a full production line covering a single end-to-end API line (cell culture through purification).

Your New Role

You will lead a team of 6-12 Investigators overseeing deviations for a single end-to-end API line (cell culture through purification). Having just reduced a significant backlog, the focus now is to stabilize and optimize the deviation process, reduce lead time, and strengthen right-first-time quality and audit readiness—without compromising GMP compliance or shop-floor support.

You will be part of the line’s leadership group and report to the Associate Director for Drug Substance Manufacturing Compliance Support.

You will uphold our People Fundamentals, drive standardization and LEAN practices, and collaborate closely with Manufacturing, QA, MSAT, Engineering, and Customers.

Key responsibilities

• Lead, coach, and develop a high-performing team of Investigators.
• Set direction and priorities, manage workload, and ensure motivation and accountability.
• Own daily/weekly planning, triage, and queue management to meet end-to-end lead time targets.
• Ensure high-quality investigations, robust root cause analysis, effective CAPAs, and strong deviation documentation across USP and DSP.
• Drive standard work, visual management, and performance metrics (cycle time, aging, RFT).
• Optimize handovers and escalation paths with Manufacturing and QA to secure flow across unit operations.
• Build audit readiness through housekeeping, data integrity, and compliance rigor.
• Promote cross-training and capability building to enhance flexibility across USP/DSP.
• Challenge status quo and implement LEAN/continuous improvements end-to-end.
• Communicate changes, risks, and decisions clearly; follow through and close actions.
• Deliver on time per internal/customer agreements while maintaining cGMP compliance and a safety-first culture.

Your Skills & Talent

• Proven people-management experience in GMP manufacturing or quality/compliance roles.
• Strong track record in deviation management, root cause analysis, CAPA, and risk assessment.
• Operational excellence mindset; experience with LEAN, flow optimization, and visual planning is a strong advantage.
• Solid knowledge of cGMP, data integrity, and documentation standards within pharma/biotech.
• Experience interfacing with API production and both cell culture and purification operations is a strong plus.
• Excellent planning and coordination skills in a high-paced, complex environment.
• Clear, concise communicator with strong stakeholder management (Manufacturing, QA, MSAT, Engineering).
• Structured, proactive, and solution-oriented; comfortable challenging and coaching.
• Strong English communication skills; Danish is a plus.

Working Hours

Primarily Monday–Friday (daytime). Flexibility to support critical escalations or cross-shift coordination when needed.

Your New Team & Department

The Compliance Support Team consists of 6-12 dedicated Investigators focused on deviation handling across one integrated production line. Following a successful backlog reduction, the team is moving from recovery to optimization—stabilizing flow, standardizing methods, and improving lead times and right-first-time quality.

You will collaborate closely with Manufacturing, QA, MSAT, Engineering, and Planning to keep product flow uninterrupted and audit-ready.

Our environment is international and informal, emphasizing psychological safety through trust and empowerment, a high pace, and a vital life balance—with plenty of fun.

Working at FUJIFILM Biotechnologies

We offer a competitive compensation package in a site/company growing rapidly, with many opportunities for individual growth. We also offer access to fitness and an attractive canteen.

FUJIFILM 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 Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities, and technologies to manufacture advanced biologics. 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.

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 Biotechnologies Denmark 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 identity, or any other protected class.

We are part of the Fujifilm Group, and we all share the same purpose. Giving our world more smiles.

We bring diverse ideas, unique capabilities, and extraordinary people together to change the world.

FUJIFILM Biotechnologies works in strategic collaboration with biopharmaceutical and biotech companies to develop and manufacture the latest in biologics, advanced therapies and vaccines.

With production facilities in the US and Europe, we give our customers everything they need to develop and commercialize treatments and therapies effectively and efficiently to make patients’ lives better.

We are driven to revolutionize the industry through our Partners for Life mindset, seeking to build global partnerships based on trust with our customers.

Our global teams fully embrace our aspiration of being the leading and most trusted Partners for Life in the biopharmaceutical industry.