Head of Specialty Care Microbiological Control
Framingham, Massachusetts, Frankfurt am Main, Germany
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Specialty Care Quality Technical Services (SCQTS) mission is to provide support and technical expertise to enable all sites in the SC Network to supply medicines that meet the needs of patients, with less complexity, better efficiency, and highest quality standards in support of Sanofi’s patient commitment. SCQTS is designed as a service organization to provide support to sites throughout the SC Network, provide solutions to sites pain points and help drive change, provide Expertise and Corporate Support to SC Quality, and aligns with Sanofi quality strategy, supports launches and other initiatives.
SCQTS includes the following organizations:
Learning and Development
Sanofi Manufacturing System (SMS)
Deviation management tactics and reduction
Network initiative program management
Consent Decree Audit Support
POSITION OVERVIEW WITH KEY RESPONSIBILITIES:
The Head of SCQ Microbiological Control is a key role to achieve Sanofi's objectives of limiting compliance risks and product losses from microbial contamination. This role reports directly to the Head of SC Quality Technical Services and will provide technical leadership and monitor compliance related to contamination control at all Sanofi SC sites. This role requires a sincere passion for eliminating contamination from the Sanofi SC platform.
Promotes a strong culture of contamination prevention through education and awareness training
Assesses and monitors the compliance and overall effectiveness of contamination controls at each site
Ensures, in conjunction with site leads, that contamination control objectives are achieved, and obstacles are escalated appropriately
Provides technical leadership to identify best practices and ensures implementation through direct site assessment and Community Of Practice
Leads and/or participates in cross-functional teams at all levels to execute contamination control objectives
Helps develop or enhance site control strategies, as needed
Participates in site investigations and inspection responses, as needed
Represents Sanofi to regulators and professional organizations
Actively maintains knowledge of industry standards related to contamination controls
Actively develops working relationships throughout the industry
Monitor and advise on new Microbiological methods
This role has no direct reports to manage but must embody considerable leadership skills to be successful
As a leader of the organization, the role holder must mentor and inspire site personnel to achieve the company's objectives related to contamination control
The role holder must be a versatile learner who is comfortable with complexity and ambiguity, and a courageous decision-maker who is candid and direct
Role holder works autonomously and makes decisions in line with Sanofi Global Quality Policy, Standards and Processes
Role holder works directly with a number of Sanofi manufacturing sites, as well as with colleagues from other internal functions
Role holder works externally with industry groups or regulatory agencies
Role holder provides feedback on performance of site leads during management review process
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures
Being honest and treating people with respect and courtesy
Constantly striving to make Sanofi a great place to work, and a company respected for the quality of its people and products
Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs
Sanofi's leaders motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others. They are versatile learners and courageous decision makers.
Leading the Business
Sanofi's leaders are effective operating in an evolving, complex and dynamic environment, providing clear direction and instruction to direct reports, and continuously looking internally and externally for best practices and areas for improvement.
Delivering to Customers
Sanofi's leaders understand patient and customer needs and build relationships as required to meet manufacturing goals. They create a vision for the organization while continuously improving operations by holding teams accountable to high standards of performance.
Act for Change / Innovation
Strive for Results
Resource management: budget, planning, organization
Strive for Results
First degree qualification in Biology or relevant science; graduate degree preferred
10+ years of Quality experience in GMP manufacturing
3+ years of management experience
Expertise in pharmaceutical microbiology; this role must have an immense understanding of microbiology. Virology knowledge preferred
Strong knowledge of Contamination Control Strategy and Quality Risk Management principles
Detailed knowledge of regulatory requirements and industry standard practice for biologics drug substance manufacture
Aseptic fill/finish knowledge preferred
Excellent interpersonal and leadership skills
Strong written and verbal communication in English; German and French appreciated
Proven ability to successfully lead cross-functional teams
Commit to customer/patients
Act for change
Special Working Conditions:
20% international travel
Ability to gown and enter clean rooms
Above information was designed to indicate the general nature and level of work performed by employees with this job description. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.
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.
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.
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