The Team Leader Analytical Documentation is a new team leader role with personnel responsibility within the Analytical Development and Documentation department. The Analytical Development and Documentation department is part of the Global Product Management function in Integrated Supply Chain (ISC), Pharmaceutical Diagnostics (PDx). The team leader reports to the Analytical Development and Documentation department manager.

The team leader will lead and further develop a team currently consisting of 4 experienced senior and lead scientists. The primary objective of the Analytical Documentation team is general regulatory and GMP compliance; establish the quality control requirements for new products, i.e. develop, establish and justify specifications for new diagnostic imaging products and substances; support life cycle management of current product portfolio; answer requests for information from regulatory authorities; and general support to all PDx sites and functions. The team is also responsible for writing the analytical sections in dossiers submitted to health authorities for market authorization approval. The team leader will be deputy for the other team leaders and possibly also deputy for the Analytical Development and Documentation department manager.

GE HealthCare Pharmaceutical Diagnostics (PDx) provides contrast agents and molecular imaging products across the imaging modalities X-Ray, MRI, Ultrasound, SPECT and PET. Key care areas are neurology, oncology, and cardiology.

Essential Responsibilities

Provide scientific, quality and regulatory expertise, oversight and leadership for the team to deliver on the team’s objectives as described above and according to the department’s priorities.
Ensure priorities of the team are appropriately resourced with right level of competence, and that the team has the facilities and tools needed.
Maintain an up-to-date knowledge and understanding of current GxP, EHS and Lean requirements within the department’s responsibility. Continued drive for improvement.
Responsible for the scientific, quality and regulatory compliance of the team’s deliveries through review and approval of product specifications, specification justification reports, and scientific studies in accordance with GMP and applicable regulatory guidelines.
Personnel and administrative responsibility for the team and develop/coach the team members.
Proactively plan and collaborate to ensure compliant, efficient, competitive delivery of the analytical needs of the business.
Be a key leader collaborating and driving change to deliver patient needs for both marketed and new product introduction.

Qualifications/Requirements

Ph.D or MSc in Chemistry/Biochemistry/Pharmaceutics or similar qualifications, with good knowledge and experience with establishing and justifying specifications for pharmaceutical products.
Good knowledge and understanding about pharmaceutical product quality control requirements , good manufacturing practice (GMP) and the regulatory requirements for pharmaceuticals.
Good knowledge about establishment and validation of analytical methods (chemical and microbiological) and applicable guidelines.
Strong interpersonal skills, team player, able to build network across teams.
Demonstrated problem-solving skills.
Fluent English language skills essential for the role, other languages including Norwegian are advantageous.

Desired Characteristics/Skills

PhD in Chemistry/Biochemistry/Pharmaceutics
Experience as Quality Expert for regulatory dossier approval.
People and project leadership experience, but candidates who want to develop into a leadership role are also encouraged to apply
Collaborate with internal and external partners
Build networks of contacts inside and outside the organization

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