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.