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Head Of QATS - Specialty Care External Supply

Waltham, Massachusetts

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Responsibilities

Position Title

Head of Quality Assurance Technical Services (QATS) – Specialty Care External Supply

Who You Are

You are a strong communicator with a demonstrated ability to lead, engage, and motivate cross-functional project teams, both internally and externally to deliver complex analytical and scientific projects on time and within budget.

You have an innate ability to understand the end to end process, program deliverables and risks associated with quality control, analysis and product commercialization that enable you to influence decisions across all project sub teams as well as Sr Stakeholders.

You can summarize complex issues with mitigations in easy to follow presentations and clearly and succinctly present options to Sr Stakeholders to drive resolution.

You are an emotionally intelligent manager capable of employee development and direction in a fast paced and flexible environment.

You are driven by generating solutions to complex issues that branch across the Sanofi network.   

Who We Are

Specialty Care External Supply (SCES) is a Global team that manages relationships with external Contract Manufacturing Organizations (CMOs) and Contract laboratory organizations (CLOs) as suppliers of drug substance, drug products and finished goods for Sanofi Biologics. The team is focused on two areas of operation, North America and Europe/International. We oversee the external network as if it were a multi-product site, effectively managed and fully integrated into Sanofi’s business model.

Where We Are

Our North American team is located in Waltham, Massachusetts, but provides support for projects in North America and Europe/International.

Waltham is a small city located approximately 17 miles west of Boston with convenient highway access and public transport.

Job Highlights

The Head of Quality Assurance Technical Services (QATS) – Specialty Care External Supply manages a team of quality experts responsible for supporting GxP activities related to the outsourced manufacture and testing of clinical/commercial drug substance and drug product and ensuring compliance with the Quality Management System (QMS), industry practice, and regulatory requirements.  The individual works within the Quality organization and oversees Stability, Quality Control and Analytical Method Transfers (AT) activities as well as performing review and approval of technical documents.  The Head of QATS provides strategic leadership and direction, and is responsible for fostering a culture of quality and continuous improvement.

The job includes frequent inter-departmental, inter-organizational and external interactions and the incumbent will be involved with the review and approval of CMC dossiers, variations, renewals, annual reports, site registrations and territory extensions as needed. The position also supports the development and management of quality agreements between Sanofi and internal/external parties as well as the financial management of analytical purchase orders for CLO testing activities and reagents.

BASIC QUALIFICATIONS:

Bachelor’s degree with scientific background or equivalent and 10+ years of experience in Quality Control and/or Quality Assurance

OR

Master’s degree with scientific background or equivalent and 8+ years of experience in Quality Control and/or Quality Assurance

5+ years in the Biotech/Pharmaceutical industry

2+ years in a supervisory role

PREFERRED QUALIFICATIONS:

Broad knowledge and experience of EU/US GMPs for the biotech/pharmaceutical industry, with an understanding of worldwide regulatory requirements (e.g. GMP, GDP, ICH)

In-depth understanding of quality and regulatory systems and management tools

Ability to coordinate and lead diverse teams in evaluation of GxP quality systems

Problem solving, technical writing and verbal communication skills - Clearly conveys information and concepts/principles

Ability to multi-task effectively

Demonstrated ability to perform work that consistently requires independent decision making and the exercise of independent judgment and discretion

Experience with using operational excellence tools to drive continuous improvement

Terms of Employment

  • The hired candidate will have a team of 8 direct reports
  • Up to 15% domestic /international travel may be required for this position
  • The candidate will work first shift (Monday – Friday)
  • Up to 2 days of working remote permitted (currently extended due to Covid-19)

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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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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