QC Raw Materials PCU Leader

QC Raw Materials PCU Leader

Requirements

• Bachelor’s Degree in a science or technical field and 10 years of experience in pharmaceuticals or a related industry – required.
• 6+ years in a management/supervisory position – required.
• An equivalent combination of education and experience – may be considered.

Responsibilities

• Responsible for the Chemistry operational and technical services functions within the Quality Control Raw Material organization
• Leads chemical raw material onboarding, testing, and lifecycle management
• Responsible for method development, validation and optimization
• Directly responsible for all out-of-specification/unexpected results, laboratory events, and quality events regarding chemical raw materials in compliance with federal regulations and Sanofi standards
• Facilitates the implementation and maintenance of Quality methods, processes and operations for new or existing products and/or technologies
• Participates in department budget planning
• Maintaining a safe, efficient, functional and compliant laboratory developed to the required standards in accordance with site and corporate guidelines
• Developing strategies to continuously improve data management practices and test method reliability and repeatability
• Ensure inspection readiness and actively participate and lead audits as it pertains to impacted areas
• Actively influencing the development and formalization of corporate laboratory control standards, policies and guidelines
• Contribute to framework for department objectives, operation schedule, processes and budgets
• Providing effective leadership including developing and implementing objectives and goals, performance reviews, training and development, and supporting workforce diversity in alignment with site priorities
• Ensuring compliance with all legal and business requirements and Sanofi policies and practices
• Provides Raw Material expertise to the Sanofi network. Ability to work cross functionally both internally to Northborough as well as with other Sanofi sites.

Preferred Qualifications

• Experience reading and interpreting complex documentation for compliance with procedures, standards, assay validation and qualification
• Experience demonstrating initiative and attention to detail
• Demonstrated strong understanding of the pharmacopoeias (US, EU, JP, and ChP)
• Proven reliable communication skills, good presentation and influencing skills and the ability to interact and gain the support of senior management
• Skilled in achieving results and managing others to achieve corporate, site, and departmental objectives
• Proven ability to work cross-functionally within the greater Sanofi network