About The Job
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 in 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 a 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 driving priority and transformative initiatives across M&S.
The team members of Global M&S Services Hubs will act as partners to the M&S organization in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes from the hubs.
Key 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.
Ensures that systems, procedures, and methodologies are in place to support outstanding service delivery.
Takes accountability for service delivery performance, meeting stakeholder expectations, and driving future demand.
Provides accurate and regular reports to management on performance of service delivery.
Leads personnel management, including staff recruitment, performance assessment, training, and mentoring.
Builds strong relationships with teams and stakeholders to enable effective dialogue exchange between departments.
Provides 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.
Ensures compliance with Corporate and Divisional QA requirements and identifies and resolves Quality gaps and issues relating to product design, manufacturing quality programs, and product start-ups at TPMs and CMOs.
Supports Root Cause Analysis (RCA) investigations of quality events as required.
Utilizes understanding of QA systems and problem-solving tools to provide alternative solutions to quality issues.
Leads/supports the Quality Compliance team ensuring cGMP compliance and inspection readiness.
Manages supplier audit programs and follows up on regulatory audits.
Oversees Regulatory Intelligence and contributes to Quality Risk Management on-site.
Identifies and proposes process and procedure improvement proposals.
Tracks market developments and regulatory changes.
Contributes to team effectiveness, identifies risks, formulates improvements.
Manages work processes efficiently, respecting laws.
Proactively monitors FDA, EMA requirements, shares knowledge.
Coaches and directs the team, conducts evaluation interviews, and assesses training needs.
Provides an assessment of supplier's quality in place with regards to material compliance, as well as regulatory of CAPA for Third Party sites.
Acts as a local quality contact between the Suppliers, Global Quality Suppliers & IA sites to facilitate exchange of quality information.
Supports audits led by other auditors when specific expertise is needed (e.g., for cause audits with user sites representatives, highly sophisticated topics).
Organizes day-to-day agenda according to workload defined by the group.
Establishes monthly reports and indicators for priority decisions.
Conducts on-site and remote audits of GxP and Health Regulated Third Party vendors to ensure compliance with regulations and company policies.
Prioritizes audit planning to meet audit, assessment, and monitoring plans.
Collaborates with stakeholders regionally for inspection preparedness.
About You
Experience:
10+ years of Compliance or Auditing experience in the pharmaceutical industry.
Thorough knowledge of cGMPs, Code of Federal Regulations in drugs and biologics.
Knowledgeable in Quality functions of the 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.
Works 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 the 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 health insurance, out-patient benefits along with a range of family-friendly policies such as maternity, paternity, and solo parent leaves to name a few.#J-18808-Ljbffr