דרושים Qa Systems Compliance Lead ב-Ge Healthcare ב-Netherlands, Eindhoven

Essential Responsibilities

• Heading a logistics team of 3 coordinators, 4 specialists (hiring, evaluating, coaching, instructing);
• Oversee the activities of third-party logistics providers, ensuring adherence to company policies and regulatory requirements;
• Monitor and evaluate the performance of 3PL partners, addressing any issues or discrepancies;
• Steering and supervising projects;
• Manage the relationship with carriers, freight forwarders; representing the business by leading monthly and annual business reviews;
• Ensure compliance with Good Distribution Practices (GDP) and other relevant regulations;
• Address and follow up any non-compliance issues promptly and effectively (Ensure the meaningful and timely resolution of Deviations, Investigations, CAPA’s, complaints and change controls);
• Supervise the compliance of the team (trainings, work instructions, overlooking the processes);
• Understanding and controlling logistics costs (airfreight rates, road linehauls, taxes).

Basic Requirements

• Bachelor degree in Logistics, Supply Chain or related;
• In-depth knowledge of 3PL operations and cold chain logistics;
• Experience in leading a team;
• Knowledge of GDP and other relevant regulatory requirements;
• Fluent English, knowledge of Dutch is a plus;
• Excellent communication skills;
• Full-time availability.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support

Essential responsibilities

• Key member of the Quality Leadership Team contributing to the overall success and direction of the Eindhoven site.
• Ensure full quality and regulatory compliance of the facility, while driving process effectiveness and efficiency at the site.
• Proactively identify and address potential quality and compliance issues, working collaboratively with cross functional teams to implement preventive measures.
• Collaborate and lead/integrate quality activities and considerations for site expansion and change activities
• Work with Manufacturing, Engineering, Validation and NPI teams to drive changes that will reduce quality issues and result in higher long-term reliability.
• Lead and coordinate change projects from Global Quality at the Eindhoven site to ensure future readiness
• Proactively leading and supporting (site) projects and process improvement initiatives from a Quality perspective.
• Lead and support critical investigations and problem-solving on site as needed.
• Utilize data driven insights to identify trends, root causes and areas for improvement.
• Drive risk reduction proactively leveraging the site risk register
• Benchmark other sites and industry standards to drive best in class practices
• Ensure the site and business are fully prepared for external and internal compliance inspections, aiming for non-systemic results and no critical findings. Collaborate closely with business partners to maintain audit readiness at all times.
• Have external focus to understand business and Quality trends in the global supply chain and implement best practices in Eindhoven site.
• Identify skills and competency gaps in the quality teams, providing leadership and direction within own functional remit.
• Improve and promote a strong Quality Culture across the site.
• Complying with Environment, Health & Safety (EHS) Policies and applicable laws and regulations.

Basic qualifications and requirements

• Relevant academic degree or academic level obtained by working experience in Life Sciences.
• Minimum of 5 years demonstrated knowledge and experience in pharmaceutical industry regulations, including GMP Eudralex Annex 1 and data integrity guidelines, Quality Management System tools, equipment qualifications and continuous improvement methodologies.
• Experience in conducting audits to verify adherence to cGMP guidelines.
• Experience in leading, coaching and developing employees.
• You have proven Quality Operations experience of managing teams in a fast-paced and complex environment using LEAN mindset, principles, preferably in a pharmaceutical environment.
• Proven track record of driving projects forward and delivering results without supervision.
• Strong communication and collaboration skills to work effectively with cross-functional teams and regulatory bodies.
• You are a confident decision maker and effective communicator with strong leadership skills.
• Actively engaged and proactive in driving initiatives and change.
• Clear thinker who can analyze data to establish a direction to proceed.
• Excellent problem-solving skills and the ability to lead investigations.
• Ability to adapt to constant change and influence positive change effectively.
• Strong organizational skills.
• Excellent verbal and written communication skills in Dutch and English.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support

Essential Responsibilities

• Lead, engage and manage a team of QA professionals, providing guidance, support, and development opportunities.
• Oversee and plan day-to-day QA systems activities, ensuring compliance with regulatory requirements and company standards.
• Lead the maintenance of quality management systems, such as document management, handling of deviations, investigations, CAPA and Change Control, training management, auditing, regulatory intelligence and risk management in compliance with GxP.
• Identify and implement opportunities to improve quality systems.
• Oversee supplier management, ensuring effective communication and collaboration with global supplier quality teams.
• Ensure timely completion of quality records (e.g. deviations, investigations, CAPA, Change Control) and actively follow up with team to ensure completion.
• Ensure timely completion of periodic reviews and document updates.
• Review and implement updated (global) procedures.
• Oversee and support the preparation and execution of the Quality Management Review (QMR) process.
• Execute the self-inspection program to ensure continuous compliance and improvement.
• Act as the first point of contact for QA systems related inquiries and issues.
• Develop and implement QA procedures and best practices.
• Collaborate with cross-functional teams to support operational tasks, continuous improvement initiatives and projects.
• Execute, report and monitor on QA performance metrics, identifying areas for improvement.
• Review and approve various documents (e.g., procedures, validation, project) and quality records (e.g., deviations, investigations, change control, CAPA).
• Comply with Environment, Health & Safety (EHS) Policies and applicable laws and regulations.

Basic Requirements and Qualifications

• Minimum bachelor degree in a relevant field (e.g. Life Sciences, Pharmacy, Chemistry);
• Demonstrated strong knowledge and experience in GMP and Quality Assurance within the pharmaceutical industry;
• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies and understanding of site level products and related processes;
• Experience in leading, coaching and developing employees.

Desired Characteristics

• Effective interpersonal skills engages effectively with team members and stakeholders, fostering strong working relationships.
• Demonstrates drive and positive energy: ability to lead, develop, inspire and motivate the team.
• Strong organizational skills.
• Ability to adapt to constant change and influence positive change effectively.
• Excellent verbal and written communication skills in Dutch and English.
• Ability to make decisions under pressure, take ownership for actions and lead by example.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support

Essential Responsibilities

• Lead, engage and manage a team of Qualified Persons, providing guidance, support, and development opportunities.
• Oversee and plan day-to-day QA operations, ensuring compliance with regulatory requirements and company standards.
• Act as the first point of contact for operational and QA-related inquiries and issues.
• Make informed decisions regarding quality matters, ensuring timely and effective resolution.
• Coordinate and manage batch release processes (final product and raw materials), ensuring all products meet quality standards before release.
• Oversee and handle customer complaints efficiently, ensuring thorough investigation and resolution.
• Support writing and reviewing of Product Quality Reviews (PQRs) to ensure comprehensive documentation of product performance.
• Conduct trending analysis to identify and address potential quality issues proactively.
• Connect with Regulatory Affairs (Chemistry, Manufacturing, and Controls (CMC)) to ensure compliance with regulatory standards and support variations in product submissions.
• Develop and implement QA procedures and best practices.
• Collaborate with cross-functional teams to support operational tasks, continuous improvement initiatives and projects.
• Review and approve various documents (e.g., procedures, validation, project) and quality records (e.g., deviations, investigations, change control, CAPA).
• Execute, report and monitor on QA performance metrics, identifying areas for improvement.
• Comply with Environment, Health & Safety (EHS) Policies and applicable laws and regulations.

Basic Requirements and Qualifications

• Academic degree or academic level in a relevant field (e.g. Life Sciences, Pharmacy, Chemistry);
• QP qualification;
• Minimum of 5 years demonstrated strong knowledge and experience in GMP and Quality Assurance within the pharmaceutical industry, preferably in sterile manufacturing;
• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies and understanding of site level products and related processes;
• Experience in leading, coaching and developing employees.

Desired Characteristics

• Effective interpersonal skills engages effectively with team members and stakeholders, fostering strong working relationships.
• Demonstrates drive and positive energy: ability to lead, develop, inspire and motivate the team;
• Strong organizational skills;
• Ability to adapt to constant change and influence positive change effectively;
• Excellent verbal and written communication skills in Dutch and English;
• Ability to make decisions under pressure, take ownership for actions and lead by example.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support