Sanofi Group Deputy Director R&D Quality US in Swiftwater, Pennsylvania

Provides site leadership and direction to R&D for quality and compliance systems in order that quality practices are developed and maintained for clinical testing laboratories in GCI and for early phase manufacture, testing, and release of clinical trial materials performed internally at Swiftwater or with external CMO/CRO partners.

Directs a small team of quality professionals to ensure effective GxP compliance programs are in place in site R&D functions, based on Global R&D Quality strategy, and in accordance to applicable regulations and company standards. Accountable for unit performance based on company, quality and project objectives, and for development of an Annual Quality Plan based on site performance metrics. Responsible to promote a quality culture mindset that ensures compliance and drives quality continuous improvements.

Represents R&D SQO Swiftwater on the R&D Quality Leadership Team to establish priorities, define initiatives for improvement, develop and manage the budget. Acts as a subject matter expert for local R&D functions on quality –related topics.

KEY ACCOUNTABILITIES

Management of R&D Site Quality Systems - 40%

  • Provides direction, guidance and education to R&D with regards to quality and compliance (GLP, GCP and GMP) to ensure adherence to applicable regulations, and to Sanofi Quality policies, standards and procedures. Maintains an active collaboration with global R&D SQO and local IA Quality as needed.

  • Oversees the implementation of a control system and release of materials and products handled at the site according to GXP and regulatory requirements.

  • Acts as primary liaison with R&D Quality Risk Manager on the R&D SP Quality Leadership Team to maintain site QRM needs for risk-mapping and remediation.

Team Leadership - 25%

  • Manages the site R&D Quality team and plans and coordinates activities and their priorities accordingly.

  • Ensures good communication with staff, establishing clear performance expectations/evaluation and providing regular feedback. Defines programs to enhance skills for existing staff, and training for new staff.

  • Provides quality support and resources to R&D senior management as needed to ensure project and action timelines are met.

  • Manages and facilitates workload distribution within the team to ensure time-scheduled deliverables are met.

Audits and Inspections - 15%

  • Provides leadership and expertise for site inspections/ inspection readiness, for internal audits, and third party external audits.

  • Ensures appropriate quality oversight of third party suppliers and sub-contractors, including appropriate quality agreements and audits are in place.

  • Provides subject matter expertise during external and internal inspections and audits defending the programs and the individual quality systems and providing timely and completed responses to audit observations.

Continuous Improvement – Performance – Quality Culture - 15 %

  • Supports local and global initiatives for improvement, execution and/or development of quality systems within Research & Development.

  • Reports site quality metrics to senior management of Quality, GCI and other R&D Stakeholder functions

  • Defines annual evaluation programs based on quality indicators and metrics for performance, and supports development activities and follow up on corrective actions.

Oversees compliance with Employment and Health & Safety - 5%

  • Oversees and monitors compliance with employment and health and safety legislation to ensure that team works under the policies, procedures and regulations applicable to the Swiftwater site.

  • Responds promptly to all health and safety concerns or incidents, supports investigation of incidents and work-related illnesses, and completes the appropriate documentation in a timely manner.

CONTEXT OF THE JOB/MAJOR CHALLENGES

  • The incumbent is responsible for managing the quality and compliance associated with the manufacturing and testing of clinical trial material (CTM), plus quality oversight for clinical sample laboratory testing in accordance with GxP regulations, standards, and internal requirements.

  • He or she must remain current of the changing regulatory environment and effectively apply quality risk management approaches. They must be able to defend programs and provide professional support during internal and external audits and inspections in a competent and convincing manner.

  • The position requires strong organization and a good level of autonomy. The incumbent must provide leadership, management and communication skills to support direct reports and senior management needs. Decisions making is key and will require investigation or interpretation of information received from multiple sources.

  • An ability to negotiate and communicate with people in a positive manner while identifying, discussing, and rectifying problems is a requirement of the position. Interactions can be with people across multiple international sites for the different GxP areas of R&D.

DIMENSIONS/SCOPE

  • This is a management position with 3 to 5 direct reports, and requires daily guidance and management responsibilities to be provided to the team.

  • The position requires that the incumbent interact with R&D colleagues as a representative of R&D SQO on a consultant/expert basis.

  • The accountability of this position is local, however, quality decisions made and actions taken may have an impact of R&D departments across SP R&D sites. Accountable includes final approval of clinical trial materials manufactured from the SWT site or managed locally under CMOs.

  • The position generally operates in an office setting which requires intense concentration and visual examination of numerous documents. Vaccination may be needed for select areas of audit and self-inspection. A minimal amount of travel for audits and global meetings.

BASIC QUALIFICATIONS

(Required education, experience, certifications and competencies)

Education/Experience

  • (Minimum) Bachelor of Science Degree, specializing in Biology, Microbiology, Biochemistry

  • 10-15 years related experience in the Pharmaceutical Industry

  • Excellent problem solving, report writing and communication skills based on global interaction

  • Excellent knowledge of the GMPs for US, Canada and Europe. Familiarity with GLP, GCP and GCLP is an advantage

  • Prior supervisory experience and ability to manage a group of Direct reports

Certifications

  • ASQ Certified Auditor

  • ISO Certified Auditor

  • Quality System certification training from a recognized institution are all assets

PREFERRED QUALIFICATIONS

EDUCATION:

(Preferred) Advanced Degree, specializing in Immunology, Microbiology, Biochemistry or other relevant discipline

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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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

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