Copenhagen, Denmark

Are you a Quality Scientist looking for a new career opportunity? Do you enjoy working cross functional and have exposure to all –levels internal clients? Our Quality Systems team is growing and we are looking for a new colleague. If you like continuous development and growth AGC Biologics is the place to be.
About the Role
Do you have a quality compliance background, and do you enjoy collaborating with internal and external partners, to prepare and execute successful audits and inspections? This may be just the role for you!

Our Quality Systems team is expanding, and we are looking for a diligent and customer-oriented Quality Systems Scientist to join our team.

About Quality Systems:
Quality Systems is an important part of the Quality organization. You will be joining a diverse team of highly qualified colleagues, all with several years of experience within quality assurance.

The Quality Systems team is responsible for maintenance and development of our quality systems for etc. deviation, CAPA, change management, complaints, training management, and document control. We also have oversight of the supplier qualification program, internal and external audits, regulatory inspections, and customer quality agreements.

We are also actively involved in the constant development and improvement of the quality system and our facility in Søborg.

The team works closely together with the Quality Operations team, and routinely collaborates with partners across all functional areas at the site and globally, to ensure all quality-related activities are carried out effectively, efficiently, and in compliance with cGMP. We keep an open communication with focus on a high level of professionalism. We are open-minded and committed to providing high-quality service to our colleagues in the rest of AGC Biologics and – and to our customers, as well.

The role:
As a Quality Systems Scientist, you will be involved in various daily operational tasks in a dynamic and challenging environment. Together with the team, you will be an internal consultant on quality and regulatory issues for our quality control, production, development, and engineering departments. You will support internal and external audits, by ensuring compliance to regulatory requirements and applications as well as providing regulatory guidance.

Principal Responsibilities:

• Routinely interface with internal and external partners to coordinate regulatory inspections and customer audits, and to prepare responses to observations.
• Participate in regulatory and client audits by serving as a host, co-host, back-room manager, assembler, or request verifier.
• Drive collaboration across site functions to remediate top compliance risks and engage in cross-functional planning to leverage resources to improve speed of resolution.
• Implement key inspectional processes such as compliance risk assessment, presenter preparation, logistical infrastructure, inspection staff training program for inspection speakers & logistical support staff.
• Continuous development and management of internal audit program
• Support management of quality agreements and facilitation of cross-functional review
• Provide critical review of applicable documentation supporting customer regulatory applications, provide gap analysis of submissions based on regulatory requirements; anticipate Health Authority responses and communicate areas of risk to project teams and line management.
• Routinely present information to executive management related to site preparation status, needed resources and/or roadblocks.

Your profile:
You are passionate about compliance and like to keep up to date with regulatory practices and requirements. You have direct experience supporting multiple functions in a pharmaceutical or a regulatory industry and have experience with participate in inspections and audits by serving as a host, co-host or back-room manager.

Education/Training:

• Master’s degree in Natural Science, PhD, or equivalent.
• A minimum of 2 plus years’ experience required.
• Regulatory and Quality experience is preferable.
• Familiarity with regulatory requirements from FDA, DMA, EMA, and/or other regulatory agencies.

Soft skills and Competencies:

• Strong written and verbal communication skills
• Actively develops and maintains strong professional relationships building trust and respect across the organization.
• Lead through influence, effectively build alignment and collaborate with multiple stakeholders.
• Assess performance roadblocks and develop appropriate solutions.
• Facilitate organizational change related to quality systems across multiple functions.

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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.