Quality Assurance Operations Manager – Drug‑Device Combinations

About the role

Adalvo seeks an enthusiastic Quality Assurance Operations Manager to lead quality oversight for drug‑device combination products and medical devices. The role supports third‑party manufacturers, API suppliers and service providers, ensuring compliance with global regulatory requirements.

Key responsibilities

• Act as the Quality Operations SME for drug‑device combinations, guaranteeing compliance with MDR, 21 CFR, US QMSR, ISO 14971, ISO 13485 and related standards.
• Support new product introductions, technology transfers and regulatory registrations.
• Plan and execute supplier and CDMO audits, negotiate quality agreements and drive CAPA implementation.
• Review and approve all quality documentation for development projects, including specifications, master batch records, validation protocols, risk assessments and change controls.
• Oversee GMP and GDP compliance of CDMO/service‑provider operations, manage complaints, recalls and change communications.

Required profile

• University degree in pharmacy, chemistry or a related scientific discipline (minimum Bachelor’s).
• At least 8 years of experience in pharmaceutical production or control, with strong knowledge of EU‑GMP, GDP and international GMP standards.
• Extensive experience with drug‑device combination products (pre‑filled syringes, injection pens) and medical device regulations.
• Hands‑on experience with regulatory inspections (EMA, FDA, ANVISA, etc.) and supplier audits.

Required skills

• Regulatory standards: MDR 2017/745/EU, 21 CFR, US QMSR, ISO 14971, ISO 13485, UNI ISO/TR 24971.
• Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) expertise.
• Audit execution and CAPA management.
• Quality documentation review and risk assessment.
• Proficient English and solid computer skills.

What we offer

• Exciting challenges with daily learning opportunities.
• Supportive, collaborative environment where ideas are valued.
• Career development through ongoing training and mentorship.
• Competitive compensation and recognition programs.
• Fun, inclusive culture that celebrates team successes.