Site Quality & Regulatory Director

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

For our Client we are looking for an experienced Quality & Regulatory Director to lead the Quality Assurance, Quality Control and Regulatory Affairs functions within a pharmaceutical manufacturing environment.

The role combines strategic leadership with operational responsibility for quality, GMP compliance and regulatory matters, with particular focus on aseptic manufacturing and biological medicinal products.

Responsibilities:

• Lead and develop the QA, QC and Regulatory Affairs functions and their teams
• Maintain and continuously improve the Pharmaceutical Quality System (PQS) in compliance with EU GMP requirements
• Oversee key Quality processes, including deviations, CAPA, Change Control, OOS/OOT, complaints, risk management, supplier qualification and batch review/release
• Ensure effective operation and GMP compliance of Quality Control laboratories, including analytical and microbiological testing, stability programmes and Data Integrity
• Provide Quality oversight of sterile and aseptic manufacturing, including EU GMP Annex 1, Contamination Control Strategy, environmental monitoring and APS/media fills
• Ensure appropriate Quality oversight of biological manufacturing, including recombinant proteins, upstream/downstream processes, fermentation, purification and analytical control
• Lead regulatory activities related to Marketing Authorisations, variations, renewals, submissions and product lifecycle management
• Lead preparation for and management of GMP and regulatory inspections, audits and remediation activities
• Develop the company's Quality strategy, establish Quality KPIs and act as a strategic Quality partner to the CEO and Management Board
• Build a strong Quality culture and ensure effective collaboration with Manufacturing, MS&T, Engineering, Validation, R&D and Supply Chain

Requirements:

• University degree in Pharmacy, Biotechnology, Chemistry, Biology, Biochemistry, Pharmaceutical Sciences or a related Life Sciences discipline
• Minimum 10 years of experience in the pharmaceutical and/or biotechnology industry
• Strong experience in Quality Assurance and/or Quality Control within a GMP manufacturing environment
• Proven experience in a senior Quality leadership role and managing multidisciplinary teams
• Strong knowledge of EU GMP, Pharmaceutical Quality Systems, CAPA, Change Control, OOS/OOT, Quality Risk Management and Data Integrity
• Proven experience with GMP inspections, regulatory inspections and audits
• Experience or strong exposure to Regulatory Affairs, regulatory submissions and product lifecycle management
• Strong leadership, stakeholder management and communication skills, with the ability to operate effectively at senior management level
• Experience in sterile/aseptic manufacturing and EU GMP Annex 1 is highly desirable
• Experience with biological products, recombinant proteins, biosimilars or other complex biological medicines is a strong advantage

What we offer:

• The opportunity to play a key role in the continued success and development of a leading international biotechnology company
• The chance to be part of a biotechnology organisation setting high quality and industry standards on a global scale
• Annual performance bonus, based on the achievement of both company and individual objectives.
• Comprehensive benefits package, including a flexible benefits platform, extensive private medical care, employer-funded life insurance and sports card co-financing