Director, Quality Assurance, Quality Control & Regulatory Affairs

Make quality matter. Make a difference to patients.

At BIOTON, we are committed to delivering high-quality pharmaceutical products that make a real difference to patients' lives. As a pharmaceutical manufacturer specializing in recombinant human insulin, we operate in a highly regulated GMP environment where product quality, patient safety and regulatory compliance are fundamental to everything we do.

We are looking for an experienced and business-oriented Director of Quality Assurance, Quality Control & Regulatory Affairs to lead our QA, QC and Regulatory Affairs functions, strengthen our quality culture and ensure the highest standards across our manufacturing and regulatory activities.

Reporting directly to the CEO, you will play a strategic role in shaping the company's Quality and Regulatory agenda, working closely with the Management Board and cross-functional leadership teams.

Miejsce pracy: Macierzysz (pow. warszawski zachodni)

Region: mazowieckie

Opis stanowiska

Your Key Responsibilities

Quality Assurance

• Lead and continuously improve the Pharmaceutical Quality System (PQS) in accordance with EU GMP and applicable regulatory requirements.
• Ensure effective management of deviations, CAPAs, change control, investigations, complaints, audits and quality risk management.
• Maintain a state of continuous GMP and inspection readiness.
• Promote a strong quality culture and ensure appropriate independence of Quality from manufacturing operations.

Quality Control

• Lead QC laboratory operations, covering chemical, analytical and microbiological testing of raw materials, intermediates, active substances and finished products.
• Ensure the reliability, integrity and traceability of analytical data.
• Oversee analytical method validation, stability studies, OOS/OOT investigations and laboratory compliance.
• Drive continuous improvement in laboratory performance and testing processes.

Aseptic Manufacturing & Contamination Control

• Ensure compliance with applicable sterile and aseptic manufacturing requirements, including EU GMP Annex 1.
• Oversee the implementation and effectiveness of the Contamination Control Strategy (CCS).
• Ensure robust environmental and microbiological monitoring, cleanroom control, aseptic process validation and media fill / aseptic process simulation activities.
• Lead investigations into contamination events and ensure effective preventive and corrective actions.
• Work closely with Production, Technical Operations, Engineering and Validation to maintain robust contamination prevention systems.

Regulatory Affairs

• Lead the regulatory strategy and oversee the maintenance of marketing authorizations and regulatory dossiers throughout the product lifecycle.
• Ensure timely management of submissions, variations, renewals and regulatory commitments.
• Represent the company in interactions with regulatory authorities and support successful inspections.
• Assess the regulatory impact of product, process, manufacturing and analytical changes.

Strategic Leadership

• Develop and execute the Quality and Regulatory strategy in alignment with business objectives.
• Lead, develop and inspire the QA, QC and Regulatory Affairs teams.
• Advise the CEO and Management Board on quality risks, compliance and regulatory matters.
• Build effective cross-functional partnerships and embed quality into everyday business decisions.

Wymagania

Essential Requirements

What we are looking for

• University degree in Pharmacy, Biotechnology, Chemistry, Biology, Biochemistry or a related life sciences discipline.
• Significant experience in the pharmaceutical or biotechnology industry, including a senior leadership role in Quality Assurance, Quality Control and/or Regulatory Affairs.
• Strong, proven experience in a GMP-regulated pharmaceutical manufacturing environment.
• Practical experience in aseptic manufacturing and contamination control.
• In-depth knowledge of EU GMP, including Annex 1, Pharmaceutical Quality Systems and quality risk management.
• Proven experience in GMP inspections, regulatory audits, investigations and CAPA management.
• Strong leadership skills, strategic thinking and the ability to make sound, risk-based decisions.
• Excellent communication and stakeholder management skills.

Additional Advantages

• Experience in biological medicinal products, recombinant proteins or insulin manufacturing.
• Knowledge of biotechnological manufacturing processes, including fermentation and purification.
• Experience leading multidisciplinary Quality and Regulatory Affairs teams.

Oferujemy

What We Offer

• A senior leadership position with direct reporting to the CEO.
• The opportunity to shape the Quality and Regulatory strategy of an established pharmaceutical manufacturer.
• A meaningful role in an industry focused on patient safety and the availability of essential medicines.
• The opportunity to lead and develop specialist teams in a complex GMP manufacturing environment.
• Close cooperation with the Management Board and key business functions.

Aplikuj

Administratorem Twoich danych osobowych jest BIOTON S.A. Dane będą przetwarzane w celu prowadzenia procesu rekrutacji. Więcej informacji dotyczących sposobu przetwarzania danych osobowych znajdują się pod adresem: https://bioton.com/polityka-prywatnosci/