Compliance Manager SCM

at  AGC Biologics

THE JOB

This is an excellent opportunity for someone truly interested in making a difference on current operations as well as prepare us for the future. We are looking for a Compliance Manager for our SCM operation, who has an interest in Compliance and can develop and implement new processes, support our new facility project deliveries as well as manage a team of highly skilled employees.
To succeed in the job, you thrive in a fast-paced environment. You have a strong desire to create a foundation, maintain operational excellence and contribute to the development of the supply chain. You naturally create a positive and inspiring environment around you and lead by being a good example. You will take ownership securing timely deliveries, flow and visibility, support operations during audit and quality event as well as securing timely audit response and timely and accurate reports to KPI’s.

QUALIFICATIONS

• Relevant academic degree, Master, Bachelor’s, Pharmacist, or equivalent experience from previous position and have an interest of working with quality and compliance in the pharmaceutical industry.
• Demonstrated leadership abilities with respect to operations and personnel management.
• You will need very good communication skills and a positive mindset in order to interact with both internal stakeholders and suppliers. You take pride in consistently delivering high quality work, on time and in a pro-active way. On top of that, you can prioritize your assignments in an ever-changing and dynamic environment, where you constantly estimate the consequences and risks in the decisions you make.
• You have solid GMP/GDP and compliance background from pharmaceutical industry or similar.
• You have a structured way of working, strong analytical skills, winning and positive personality with a wish of making a difference every day in a hectic environment.
• Thorough knowledge with regulatory audits and Costumer visits.
• Lean experience and understanding are an advantage.
• Advanced oral and written communications skills, ability to communicate with management, peers, and subordinates effectively.
• Fluency in Danish and English

ARE YOU PASSIONATE ABOUT COMPLIANCE IN A SUPPLY CHAIN MANAGEMENT AREA AND DO YOU WANT TO BE PART OF BUILDING A SUCCESS STORY TOGETHER WITH AN AMBITIOUS TEAM? JOIN A DYNAMIC AND INTERNATIONAL COMPANY WHERE EVERYONE IS RESPONSIBLE FOR DELIVERING RIGHT ON TIME AS ONE TEAM!

We are looking for a skilled Compliance Manager who can be part of and drive the daily management and development of Compliance operations in a supply chain department including warehousing. Are you passionate about Compliance and quality mindset? Join a dynamic and international company where everyone is responsible for delivering right on time as one team!

YOUR KEY RESPONSIBILITIES WILL BE:

• People management and development of employees including individual performance
• Development and implement new standards within Compliance and quality mindset.
• Accountable for GMP compliance, periodic reviews and inspection readiness.
• Support and hold your employees accountable for delivering results and ensure alignment in achievements across teams.
• High energy level and able to drive yourself and your team forward. Similarly, you can function as a leader throughout the organization and be a role model for our culture and values.

YOU AND YOUR TEAM ARE RESPONSIBLE FOR:

• Drive and participate in various room, equipment and shipment qualifications projects. This in close collaboration with cross functional stakeholders
• Drive and participate in various room, equipment and shipment qualifications projects. Collaborate closely with cross-functional stakeholders.
• Create, support and ensure a high level of Quality mindset.
• Preparation and maintenance of guidelines and procedures
• Acting as SME during audit, follow up on audit responses
• Serve as a Subject Matter Expert (SME) during audits and follow up on audit responses effectively and timely.
• Ability to initiate Deviation/CAPA and Change Request as needed
• Demonstrate the ability to initiate and manage Deviation/CAPA and Change Requests as required.
• Act as a project manager in cross functional quality projects
• Lead cross-functional quality projects.
• Taking part in local daily and annual GMP/GDP training
• Engage in regular local GMP/GDP training sessions on a daily and annual basis.
• Owner and reviewer of J-SOX activities in Warehouse.
• Responsibility as both owner and reviewer of J-SOX activities in SCM.
  The position demands a strong ability to communicate verbally and in writing. Position requires regular cross department/function interaction and strong diplomatic skills. To be successful in this role you will take ownership of all kind of qualification activities and securing timely closure of Deviation/CAPA/CR’s. Supply and support operations during audit and QMR/QSR and other quality events. Securing timely audit response and timely and accurate reports to quality KPI’s.