Head of Site Quality Operations | TalentAlly · Teeming.ai
TalentAlly
TalentAlly is a recruitment platform that connects diverse talent with inclusive employers, focusing on enhancing workplace diversity and inclusion. The company offers job postings, recruitment solutions, and organizes job fairs to facilitate employment opportunities for underrepresented groups. With a recent investment of $1.3 million in artificial intelligence, TalentAlly aims to improve job matching efficiency and expand its reach to diverse communities. Their business model includes premium job postings and partnerships with various organizations to enhance recruitment efforts.
TalentAlly is a recruitment platform that connects diverse talent with inclusive employers, focusing on enhancing workplace diversity and inclusion. The company offers job postings, recruitment solutions, and organizes job fairs to facilitate employment opportunities for underrepresented groups. With a recent investment of $1.3 million in artificial intelligence, TalentAlly aims to improve job matching efficiency and expand its reach to diverse communities. Their business model includes premium job postings and partnerships with various organizations to enhance recruitment efforts.
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Job Title:
Head of Site Quality Operations
Location
: Swiftwater, PA
About the Job
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
Sanofi has been one of the leaders in the vaccine industry for more than 100 years and a globally recognized partner in the prevention of infectious diseases. We believe in a world in which no one suffers or dies from a vaccine-preventable disease. The Swiftwater site is the reference site for the production of several vaccines (150 million doses produced each year) which are distributed throughout the world.
This position guarantees the Quality and Regulatory compliance of products developed, manufactured and distributed by the site in accordance with Regulatory requirements and Global Quality policies and standards. This includes providing Quality leadership across the site organization as well as developing and maintaining quality policies throughout Sanofi. These quality policies include establishing and monitoring effective compliance programs in the GMP areas as well as other quality and compliance programs influencing the business and strategic operations. The position is also a key leader in Sanofi Global Quality and Strategy. This position maintains reporting line to the VP, M&S Vaccines, US.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities:
Key Accountabilities:
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.
Scope & Dimensions:
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.
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.
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.
The function covers the entire scope of cGMP activities within Swiftwater Manufacturing & Supply.
Key dimensions: Headcount (direct and indirect), budget, product release, quality systems, etc.
The Site Quality Organization equals to about 300 - 350 headcounts.
Key indicators on which the job holder will be evaluated (WHAT in 9box): Quality indicators, regulatory inspections.
Freedom to act, level of autonomy:
Whilst remaining aligned with the site goals and strategy, keeping a teamwork approach and base on facts and evidences, the job holder has the authority:
To release or reject any of the materials, components and manufactured batches according to the relevant GMP and registered specifications and cGMP requirements.
To authorize or stop any of the manufacturing activity based on evidences of GMP and Regulatory compliance.
To define mandatory requirements to be included in cGMP projects related to any of the cGMP environment facilities, utilities, equipment, process, methods and products.
To review and approve all quality documents prior to their respective effective date and to review and approve all of the quality reports prior to their respective close-out.
To push for decisions and actions with regards to cGMP and RA compliance for the cGMP areas of the manufacturing operations of Swiftwater.
