Overview
A key client of BioTalent is looking to onboard a Head of Operations (VP level). This role is remote within the European Union with some travel. You will oversee manufacturing, supply chain, CMC, and program operations, ensuring therapies reach patients without interruption. As a key member of the leadership team, you will shape the company’s growth from a lean biotech to a leader in rare diseases, balancing innovation with operational discipline.
Responsibilities
- Develop and execute a technical operations strategy aligned with corporate goals.
- Lead Manufacturing, Supply Chain, CMC, and Program Operations at the senior level.
- Advise the COO and leadership team on risks, resources, and timelines.
- Build and manage partnerships with CMOs, CDMOs, and suppliers for rare disease therapies.
- Oversee global supply chain, technology transfer, scale-up, and supplier performance.
- Drive program operations, portfolio governance, and integrated project management.
- Ensure compliance with global GxP standards and foster a culture of quality and safety.
- Lead CMC development, including process optimization, regulatory submissions, and lifecycle management.
- Recruit, develop, and inspire a high-performing, agile team with a start-up mindset.
- Represent Technical Operations externally with regulators, partners, investors, and industry forums.
- Demonstrate 12+ years of progressive experience in biotech/biopharma technical operations, with 5+ years in senior leadership.
- Demonstrated success leading product launches and managing global supply chains.
- Deep expertise in manufacturing, supply chain, quality, and CMC throughout clinical and commercial stages.
- Track record of managing external manufacturing networks.
- Experience preparing and submitting INDs, NDAs, BLAs, and MAAs, and interacting directly with FDA, EMA, and other authorities.
- Strong business acumen, with expertise in budgeting, forecasting, and vendor management.
- Excellent leadership, communication, and stakeholder management skills.
Qualifications
- 12+ years of progressive experience in biotech/biopharma technical operations, with 5+ years in senior leadership.
- Demonstrated success leading product launches and managing global supply chains.
- Deep expertise in manufacturing, supply chain, quality, and CMC throughout clinical and commercial stages.
- Track record of managing external manufacturing networks.
- Experience preparing and submitting regulatory submissions and interacting with authorities.
- Strong business acumen, budgeting, forecasting, and vendor management.
- Excellent leadership, communication, and stakeholder management skills.
Contact
Reach out to luisa.namadila@biotalent.com for further information.
Details
- Seniority level: Executive
- Employment type: Full-time
- Job function: Other
- Industries: Pharmaceutical Manufacturing
Get notified about new Head of Operations jobs in European Union.
Copenhagen, Capital Region of Denmark, Denmark