Denmark Job Openings

AGC Biologics

Senior GMP Compliance Specialist, Supply Chain Management

Copenhagen

FULL TIME

November 21, 2024

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

Do you have a passion for compliance and thrive in a dynamic environment where stakeholder management is key? Join our dedicated team in a growing international company as soon as possible! This exciting position offers a variety of responsibilities across multiple functions, providing opportunities to make a significant impact on quality, compliance, and continuous improvement.

About the Team & Department

You will be part of the well-established Supply Chain Compliance Group, currently consisting of three employees. The team is part of the larger SCM (Supply Chain Management) department, which includes over 60 colleagues responsible for procurement, planning, warehousing, and shipping.

Our team supports all AGC production and collaborates closely with key internal stakeholders and external suppliers throughout the supply chain. We operate in an international, customer-focused environment to ensure fast and reliable support for our customers.

About the Role

For this role, we are looking for an experienced Sr. GMP Compliance Specialist with a strategic and pragmatic mindset, solid diplomatic skills, and a solution-oriented approach to engaging with stakeholders and suppliers. You take ownership, deliver high-quality work, and maintain a proactive attitude in a dynamic environment.

Your Primary Tasks Will Be…

Ensure and oversee GMP compliance of SCM documents (e.g., SOPs and TEQs), improving the compliance levels in alignment with our QMS and regulatory requirements.

Provide expert guidance and support on GMP and compliance matters across the SCM organization.

Promote a culture of quality awareness and foster a compliance-oriented mindset.

Collaborate with cross-functional stakeholders on qualification projects e.g., room, equipment, and shipment qualifications, including reviewing protocols and reports.

Create SCM documentation as part of qualification activities.

Initiate or support deviations related to SCM processes, including impact/risk assessments and root cause investigations.

Oversee and ensure timely implementation of corrective and preventive actions (CAPAs) to mitigate risks, prevent recurrence, and improve compliance.

Monitor and report monthly KPIs for deviations, CAPAs, and change controls.

Initiate or coordinate change controls, assessing their impact on SCM processes.

Support or provide GMP awareness and refresher training sessions within SCM.

Support and lead SCM optimization projects focusing on continuous improvement.

Serve as a liaison to the QA department to align and interpret GMP and quality matters.

Prepare and coordinate audits and health authority inspections within SCM, acting as an SME (Subject Matter Expert) when required and support the timely implementation of responses.

Your Qualifications…

A relevant academic degree (e.g., Master's, Bachelor's, or Pharmacist) with at least 5 years of experience in a similar role within the pharmaceutical/biotech industry.

Experience with warehouse operations, 3PL, and vendor compliance is an advantage.

Expertise in risk management/assessment, contributing to solutions that meet regulatory requirements.

Strong analytical skills, a structured approach to tasks, and a can-do attitude.

Ability to focus and prioritize effectively in a fast-paced, ever-changing environment.

Proven ability to work independently within defined responsibilities.

Excellent communication skills in both English and Danish, written and spoken.

Application

To apply, please submit your CV. We encourage you to apply, even if you do not meet every requirement.

You do not need to attach a cover letter; however, please include a summary of why you are applying in your resume/CV.

We are looking forward to receiving your application.

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (p DNA), messenger RNA (m RNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with c GMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on

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AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

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