Senior Director of Quality & Regulatory (Biotech)

Adecco Portugal; Warszawa; On-site; PLN 420,000 - 660,000; Full time

Benefits offered by this job

Annual performance bonus

Private medical care

Employer-funded life insurance

Sports card co-financing

Job summary

Adecco Portugal is assisting a leading international biotechnology company in seeking a experienced Quality & Regulatory Director to lead QA, QC and Regulatory Affairs in a pharmaceutical manufacturing setting.

The role blends strategic leadership with hands-on responsibility for quality systems, GMP compliance and regulatory activities, with a focus on aseptic manufacturing, sterile processes and biological products.

Qualifications

• University degree in Pharmacy, Biotechnology, Chemistry, Biology, Biochemistry or related Life Sciences.
• Minimum 10 years of experience in pharmaceutical/biotechnology industry.
• Strong QA/QC experience within GMP manufacturing environment.
• Senior leadership experience managing multidisciplinary teams.
• Knowledge of EU GMP, PQS, CAPA, Change Control, OOS/OOT, Data Integrity.
• Experience with GMP inspections and regulatory inspections.
• Exposure to Regulatory Affairs and product lifecycle management.
• Sterile/aseptic manufacturing experience desirable.
• Experience with biological products is an advantage.

Responsibilities

• Lead and develop QA, QC and Regulatory Affairs functions and teams.
• Maintain PQS in compliance with EU GMP requirements.
• Oversee deviations, CAPA, Change Control, OOS/OOT, complaints, risk management, supplier qualification and batch review/release.
• Ensure GMP compliance of QC labs, including analytical and microbiological testing.
• Provide QA oversight of sterile and aseptic manufacturing, including Annex 1 and environmental monitoring.
• Oversee regulatory activities for MA variations, renewals, submissions and lifecycle management.
• Lead GMP and regulatory inspections, audits and remediation activities.
• Develop quality strategy and KPIs; partner with CEO and Management Board.
• Foster collaboration with Manufacturing, MS&T, Engineering, Validation and Supply Chain.

Skills

Quality leadership

GMP compliance

Regulatory affairs

Biotech/pharma experience

Stakeholder management

Education

Life sciences degree

Job description

Adecco Portugal is assisting a leading international biotechnology company in seeking a experienced Quality & Regulatory Director to lead QA, QC and Regulatory Affairs in a pharmaceutical manufacturing setting.

The role blends strategic leadership with hands-on responsibility for quality systems, GMP compliance and regulatory activities, with a focus on aseptic manufacturing, sterile processes and biological products.