Sanofi Group Supplier Quality Lead - Finished Goods in Waltham, Massachusetts

JOB DESCRIPTION

The Quality Lead – Finished Products works within the Supplier Quality Management team at Bioverativ and is responsible for providing oversight of cGMP activities at Contract Manufacturing Organizations (CMOs) used to package and label clinical and/or commercial products. This individual is part of a multifunctional team and ensures appropriate scientific, regulatory, and quality standards are followed to assure product quality and compliance. Activities include oversight of packaging and labeling qualifications, artwork used for destination market (including version control), and review of investigations, change controls, and batch documentation. May be responsible for final product disposition depending on territory. Role may require some travel both domestic and international.

MAIN RESPONSIBILITIES

  • Provide quality oversight of cGMP external packaging and labeling operations

  • Provide quality guidance and support for investigations and change controls

  • Provide support of equipment/process qualification activities including document review and approval

  • Perform review/approval of master production records, executed batch records and disposition of product

  • Participate in multi-functional teams to support product launches in new and existing markets

  • Provide support of Bioverativ Quality Management Systems, as needed – e.g. product quality reviews, data compilation and analysis, audits, risk program

  • Travel, as needed to CMOs to support Bioverativ products

  • Participate in routine internal and external Operations Meetings

  • Escalate quality and compliance issues to quality management

  • Interface with external regulatory agencies as required

  • Establish/maintain key performance indicators (KPIs) for CMOs within area of responsibility, monitor performance, and promptly address undesirable trends

  • Develop and maintain positive relationships and network effectively across functional areas

QUALIFICATIONS

  • Experience working with external partners (e.g. CMOs, contract laboratories and suppliers)

  • Demonstrate strong leadership capabilities, but also the ability to actively listen

  • Experience with packaging and labeling processes required; additional experience with Biotech/Pharmaceutical manufacturing is ideal

  • Ability to influence in a matrix organization

  • Understanding of and ability to apply pharmaceutical/biotech cGMP regulations and guidance using a risk-based approach

  • Manage through ambiguity, work independently and prioritize the workload with minimal direction

  • Exude a passion for relationship building both inside and outside the company

  • Demonstrate excellent communication skills both internally and externally

  • Ability to multi-task and work in a fast paced and dynamic environment

EDUCATION

  • Bachelor’s degree is required. Masters is preferred or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities for this position.

  • Minimum 8 years pharmaceutical / biotechnology industry experience. Demonstrated success in working cross-functionally in a matrix organization; minimum 4 years’ experience within a Quality role.

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.

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.

Sanofi, Empowering Life