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A Range of Possibilities

Global Audit and Supplier Quality Head

date posted 06-13-2022
contract type Full time
job id R2644432
location Marcy-l'Etoile;Swiftwater, PA;

Title: Global Audit and Supplier Quality Head

Reference No. R2644432

Location: Toronto, Canada

Sanofi Pasteur: The world’s leading vaccine company

Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines.  Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe.  Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.  With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

SUMMARY OF PURPOSE/MAJOR RESPONSIBILITIES

In the context of Sanofi vaccine development under both Vaccine CMC Development and Supply (VCDS) and the mRNA Centre of Excellence (mRNA COE), the Global Audit and Supplier Quality function is responsible through audit and associated quality systems to ensure that vaccine R&D internal and subcontracted GXP operations, materials and services are compliant to applicable GLP, GCLP, cGMP and GDP requirements, Sanofi standards and Regulatory Quality Policies.   This is achieved by providing accurate, independent assessments of the quality and compliance of incoming materials and GXP service providers, clinical batch manufacture, testing and distribution, and by ensuring identified gaps are corrected.

The Global Audit and Supplier Quality Head leads a team of qualified auditors and quality professionals and reports directly to the Global Head of Vaccine R&D Quality.  He or she will work in close collaboration with stakeholders across R&D, Site Quality Operations, Clinical Batch Release, Sanofi Clinical Quality, VIA External Quality, and numerous external subcontractors.   The role contributes significantly to building and maintaining a strong quality culture for R&D vaccines.  It embraces leadership in developing people, establishing quality systems and active participation in leadership and governance committees.

KEY ACCOUNTABILITIES

Design, develop, and lead the global vaccine R&D internal and external auditing program:

  • Oversees planning and execution of GXP (GMP/GLP/GCLP/GDP) self-inspection and audits at Sanofi R&D sites, Contract Manufacturing Organizations (CMO) and Contract Research Organizations (CRO) by qualified auditors.

  • Maintains the annual and longer-term audit plan, including scoping and resourcing of audits, through cooperation with sites, operational units and third parties as required.

  • Develops auditing procedures and processes consistent with vaccine R&D requirements that support risk-based, phase-appropriate internal and external provider compliance.

  • Ensures that current and forthcoming regulatory authority requirements, industry trends, inspection results and relevant Sanofi Global Quality Documents are applied under the program.

  • Ensures GxP audit reports are written and delivered in a timely manner, and that CAPA are established and managed for identified areas of non-compliance.

Develop and execute the strategy for R&D Supplier Quality Management:

  • Ensures that incoming materials (raw materials and consumables) or services procured for vaccine R&D GXP work are from Qualified Suppliers with the ability to deliver an acceptable-grade product.

  • Ensure use of a risk-based approach to selecting, assessing, and qualifying suppliers for their ability to meet Sanofi quality requirements.

  • Ensures maintenance of up-to-date status for Quality Third Party (QTP) suppliers and subcontractors in Phenix.

  • Ensures Quality oversight and change management associated to Supplier Quality at R&D vaccine sites (change notifications, associated change controls, supplier deviations and CAPA).

  • Supports development of incoming controls /specifications and Quality Technical Agreements.

Establish direction and enable training for qualified auditors to ensure stakeholders are provided reliable quality assurance, advice, and insight:

  • Ensures auditors maintain qualified status across the GXP space.

  • Build specific expertise and competency for audit under GLP, GCLP, GMP and GDP as well as focus areas such as software systems and data integrity, sterile manufacturing, etc.

  • Ensure tools and capabilities in place for on-site, hybrid and remote audits.

  • Provides information regarding best practices, advice or consult on GxP and on quality risks.

  • Develops inspection readiness program for Vaccine R&D and proactively supports sites regulatory inspection and corporate audits.

  • Actively communicates risks with stakeholders and management.

Quality Leadership and Management:

  • Lead a global team of quality professionals embracing the Play to Win behaviors.

  • Oversee annual assessment, development and mentoring of staff to support personal growth and complete the recruitment of budgeted positions in alignment with pre-requisite competencies.

  • Establish team priorities, reports functional Quality metrics, and defines improvements that drive compliance and /or efficiency.

  • Advise stakeholders of changing quality regulations and/or guidelines and notify senior management of audit or inspection findings that would require the company take significant action to address.   

  • Represent vaccine R&D Quality on inter-departmental /GBU discussions and in key governance meetings such as the Sanofi-wide Third Parties Management group and Global Regulatory Inspection Council (GRIC).

HSE:

  • Supervises and monitors compliance with employment and health and safety legislation to ensure that employees work within the policies, procedures, and regulations applicable to their work.

  • Responds promptly to all health and safety concerns or incidents and completes the appropriate documentation in a timely manner.

  • Participates in the investigation of incidents and work-related illnesses.

CONTEXT OF THE JOB/MAJOR CHALLENGES

This position has a strong influence on the application of GxPs across vaccine R&D operations, specifically for how they relate to the assurance of quality for materials/services, manufacturing, packaging, storage, testing and distribution of clinical batches, tox lots, clinical laboratory patient samples, test kits, and quality managed ancillary supplies.   Decisions taken by the head of function can impact the work processes and activities across multiple teams, development programs and functions.

The position helps define the overall strategy and needs for improvement of Quality and Compliance across vaccine R&D sites.  For this, the incumbent must have a well-developed situational awareness and an ability to ensure decisions made regarding the level of auditee compliance are appropriate for the phase of development and type of activity under assessment.

The role requires interaction with a wide and diverse R&D stakeholder group, multiple Management and Operational levels and external stakeholders, requiring collaboration, negotiation and strong influencing skills.

DIMENSIONS/SCOPE

  • Responsibility covers global vaccine R&D across multiple countries/sites with specific accountabilities under Quality Assurance.

  • Decisions can affect work required in other functions and timelines for NV programs.

  • The role is critical for compliance and subject to routine evaluation through corporate and regulatory inspection.

  • Leads a team of 4 to 6 Qualified Senior Auditors and Supplier Quality managers.

  • Position has a high degree of autonomy and is expected to make decisions and interpretations within broadly defined requirements.

  • Contributes to global direction for vaccine R&D Quality, including alignment of Quality practices within scope of role and ensuring compliance standards are met.

  • Interacts across multiple Vaccine R&D functions, Sanofi GBU Quality units and external partners as a representative of Quality.

  • Position will require travel of 2-3 night away from home per month.

REQUIREMENTS

Education/Certifications:

  • Graduate Degree in Pharmaceutical or Life Sciences or equivalent experience.

  • Quality Systems training from a recognized institution.

  • ASQ/ISO certified auditor an advantage.

Experience:

  • Minimum 15 years of industrial/auditing experience in the pharmaceutical/biotech sterile manufacturing or quality environment.

  • Experienced GXP auditor.

Knowledge:

  • In depth knowledge of regulatory requirements, i.e. GMP, Health Canada, EU, and FDA and how they apply to vaccine development.

  • Ability to assess and apply compliance standards to operational situations.

  • Knowledge of vaccine manufacturing processes and controls.

Competencies:

  • Demonstrates Play to Win Behaviors: Stretch, Take Action, Act for Patients & Customers, Think Sanofi First.

  • Strong organizational, planning, prioritization, and decision-making ability.

  • Excellent communication (written and oral), negotiation and influencing skills.

  • Ability to build and maintain efficient professional relationships with partners and stakeholders.

  • Proactive leadership and management with a strong ability to operate in a cross-cultural and complex matrix.

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants.  Accommodations for persons with disabilities required during the recruitment process are available upon request.

Thank you in advance for your interest.

Only those candidates selected for interviews will be contacted.

Sanofi, Empowering Life

#GD-SP #LI-SP

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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