Head of Site Quality Operations

* Ensure that applicable requirements are included in development and technical transfers for an effective and efficient industrialization, regulatory submission and timely approval. Represent the site towards the concerned health authorities as the Quality head of the site with regards to product quality, safety and cGMP compliance as well.
* Oversees the
** QC activities
** to guarantee that all products are tested and compliant with applicable standards and specifications. Manage the QC testing operations in an efficient and compliant manner to guarantee product availability for market release in a timely manner and cost-effective way.
* Lead the SQC to provide direction and guidance to sustain quality and compliance. As head of Quality Department, raise compliance and quality issues and solutions/ proposals to senior management. Develop, maintain and control departmental capital and operating expense budgets.
* Provide guidance and technical support to the company for project planning, process, systems and computer validation, aseptic processes and validation, component/ product release, trending, problem investigations, product assessment, disposition, complaint management, records retention, document distribution & audit.
* Lead the site’s
** quality management system
** to ensure continuous compliance and certification.  Ensure the implementation and maintenance of
** robust quality systems, in line with global quality.
*** Develop and oversee the implementation of
** site quality roadmap
** in line with site CBN and global quality objectives and strategy.
* Support and provide guidance to Protein Sciences, NY site Quality team as needed.
* As the head of Quality, manage budget, supervise staff in accordance with Company commitment and appropriate policies and procedures.
** Lead and manage the quality team
** including hiring, training, coaching, professional development, and performance evaluation.
* As a member of the SLT (Site Leadership Team) ensure appropriate leadership and management presence. Through the functional reporting line to Corporate Quality, ensure alignment of site programs and objectives with the Corporate (Sanofi) and Global (Sanofi) functions.
* Promote a
** culture of quality
** throughout the site organization. Foster continuous improvement and economical performance,
** innovation**, and the implementation of
** new technologies, tools, and methods.
** Ensure that all site activities are conducted in
** compliance with applicable regulatory requirements
** and that valid
** manufacturing licenses
** and marketing authorizations are maintained. Ensure that the Swiftwater manufacturing operations operate in full compliance with the applicable regulations and registrations in a sustainable and consistent way for guaranteeing that manufactured products are of the appropriate quality and safety prior to the product release and throughout shelf-life.
* To ensure that a fully compliant Quality System Management (QSM) is implemented at Swiftwater  across the manufacturing operations for ensuring that the site operates in a consistent way, in compliance with the applicable regulations and registration files.
* To ensure that the products released strictly meet the requirements in both cGMP compliance of the manufacturing, testing, storage and distribution operations and registered specification for quality, purity, potency, strength and safety.
* To assess regularly the effective and compliant implementation of the QSM across the industrial operations at Swiftwater, to monitor performance and cGMP compliance, to report status to site and upper management and to define and execute action plans when necessary.
* To implement, drive and monitor a continuous improvement plan across the site at Swiftwater and with suppliers and subcontractors with regards to product/service quality, product safety and cGMP compliance.
* To define and execute the strategy related to Quality and cGMP Compliance improvement for Swiftwater aligned with the Corporate/Global strategies and goals.
* To play an active key role in the definition and implementation of site objectives as a SLT member.
* Whilst remaining…