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Head of Quality Services - Third Party Audits

Synthorx

Synthorx

Quality Assurance
Bogotá, Bogota, Colombia
Posted on Sunday, June 9, 2024

Job title: M&S Services, Head of Quality Services - Third Party Audits Bogota

  • Location: Bogotá, Colombia

About the job

The purpose of this role is to:

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference on patients’ daily life, wherever they live and enabling them to enjoy a healthier life.

As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health.

The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S. The team members of Global M&S Services Hubs will act as partners to M&S organization in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs.

Main responsibilities:

  • Leads and defines the priorities and deliverables of Hubs, fostering a culture of quality and collaboration.
  • Sets priorities for Centers of Excellence and Communities of Practice, ensuring recognition and promoting unified quality and operational excellence across all Hubs.
  • Ensuring that systems, procedures, and methodologies are in place to support outstanding service delivery.
  • Taking accountability for service delivery performance, meeting stakeholder expectations, and driving future demand.
  • Providing accurate and regular reports to the management on performance of the service delivery
  • Leading personnel management, including staff recruitment, performance assessment, training, and mentoring.
  • Building strong relationships with teams and stakeholders to enable effective dialogue exchange between departments.
  • Provide QA and Technical Support to Third Party Manufacturers (TPM) and Contract Manufacturer Organizations (CMO), TPM/CMO Operations, Affiliates, and other Stakeholders.
  • Responsible for compliance with Corporate and Divisional QA policies, procedures, standards, and specifications as well as country specific regulations depending on the TPM/CMO location and markets.
  • Ensure compliance to Corporate and Divisional QA requirements and identify and / or resolve Quality gaps and / or issues relating to product design, manufacturing quality programs and product start-ups at TPM’s and CMO’s.
  • Support Root Cause Analysis (RCA) investigations of quality events as required
  • Utilize understanding of QA systems and problem-solving tools to provide alternative solutions to quality issues.
  • Lead/support the Quality Compliance team ensuring cGMP compliance and inspection readiness.
  • Manage supplier audit programs and follow-up on regulatory audits.
  • Oversee Regulatory Intelligence and contribute to Quality Risk Management on-site.
  • Identify and propose process and procedure improvement proposals.
  • Track market developments, regulatory changes.
  • Contribute to team effectiveness, identify risks, formulate improvements.
  • Manage work processes efficiently, respect laws.
  • Proactively monitor FDA, EMA requirements, share knowledge.
  • Coach and direct the team, conduct evaluation interviews, and assess training needs.
  • Provide an assessment of supplier’s quality in place with regards to material compliance, as well as regulatory of CAPA for Third Party sites
  • Being a local quality contact between the Suppliers, Global Quality Suppliers & IA sites to facilitate exchange of quality information
  • Support audits lead by other auditors when specific expertise is needed (e.g. for cause audit with user sites representatives, highly sophisticated topic)
  • Organize day to day agenda according to workload defined by the group. Establish monthly reports and indicators for priority decisions.
  • Conduct on-site and remote audits of GxP and Health Regulated Third Party vendors to ensure compliance with regulations and company policies.
  • Prioritize audit planning to meet audit, assessment, and monitoring plans.
  • Collaborate with stakeholders regionally for inspection preparedness.

About you

Experience:

  • 10+ years of Compliance or Auditing experience.
  • 10 – 15 years of related experience in the pharmaceutical industry.
  • Thorough knowledge of cGMPs, Code of Federal Regulations in drugs and biologics
  • Should be knowledgeable in Quality functions of pharmaceutical industry.
  • Experience in conducting on site audits, inspections and facing regulatory/health authority inspections/audits.
  • Thorough knowledge of CAPA systems is required and experience is desirable
  • Thorough knowledge of and experience in application of GMP requirements
  • Experience managing third party manufacturers is preferred.
  • Experience of working on manufacturing sites is an added advantage.

Required skills:

  • Excellent problem solving and decision-making skills are critical to this position. The successful candidate must be able to demonstrate their risk-based decision-making ability.
  • Proficient in problem-solving, attention to detail, and good organizational skills.
  • Work in a team-oriented, flexible, and proactive manner.
  • Analytical skills and ability to multitask in a stressful environment.

Education:

  • Master’s or Ph.D. in Life Sciences/Healthcare, or related technical field

Languages: Excellent knowledge of English language (spoken and written)

Why choose us?

  • Bring the miracles of science to life alongside a supportive, future-focused team
  • Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally
  • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
  • Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave

Pursue Progress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

#LI-LAT #LI-HYBRID

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!