Compliance and Risk Management Principal Specialist

Við leitum að öflugum og reyndum sérfræðingi í lykilhlutverk innan Quality Compliance. Í þessu hlutverki berðu ábyrgð á því að leiða og efla Quality Risk Management ferla og sinna viðbótarhlutverkum innan Compliance, þar á meðal Regulatory og Compendial Surveillance.

Starfið er mikilvægt til að tryggja að rekstur fyrirtækisins sé í samræmi við gildandi alþjóðlegar gæðakröfur og þróun í reglugerðarumhverfinu.

(English)

We are seeking an experienced specialist for a key role within Quality Compliance. You will lead and strengthen our Quality Risk Management processes and support additional Compliance activities, including Regulatory and Compendial Surveillance.

This role is essential for keeping our operations aligned with international quality standards and evolving regulatory requirements.

Key Responsibilities

• Lead and enhance Quality Risk Management processes across the organization.

• Participate in ongoing surveillance of global regulatory guidelines (e.g., FDA, EMA, WHO) and pharmacopoeial/compendial updates (USP, EP, JP).

• Assess the impact of regulatory and compendial changes on internal processes, products, and documentation.

• Communicate regulatory changes to stakeholders and coordinate necessary cross-functional actions.

• Maintain governance frameworks that support risk identification, mitigation, and continuous improvement.

• Support audits, inspections, and compliance‑related initiatives at the site (partner audits and Health Authority inspections).

Job Requirements

• Bachelor’s or Master’s degree in a relevant field (Quality, Pharmacy, Biotechnology, Life Sciences or similar).

• Proven experience in Quality Risk Management within the pharmaceutical or biotech industry.

• Strong understanding of global regulatory requirements (FDA, EMA, WHO) and compendial updates (USP, EP, JP).

• Experience with audits and/or inspections is a strong advantage.

• Strong analytical skills and the ability to translate regulatory changes into practical internal actions.

• Excellent communication and stakeholder management skills.

• Organized, detail‑oriented, and able to work in a dynamic environment with multiple stakeholders.