Job details
Job type full-time
Full job description
Who we are:
Specialty care external supply quality (sces-q) is the quality unit responsible for gxp oversight of contract manufacturing organizations (cmos) and contract laboratory organizations (clos) and business partners involved in the manufacture, testing, and transport of sanofi productsBes q staff interact with functional units within specialty care quality (scq), sanofi sites, and other organizations within the biologics network (e.gProcurement, supply chain, finance) to ensure compliance with internal and regulatory requirements, and to disposition intermediate (e.gApi, drug substance) and finished products with minimal risk to quality or product supply.
Sces-q has responsibility for cmo and clo activities related to products treating rare diseases and blood disorders, multiple sclerosis (ms), cancer, and diabetes.
Sces-q is based in waltham, ma and frankfurt germany with satellite offices in haverhill, uk, netherlands and ghent, belgium.
Sces-q personnel may occasionally be located on-site at cmos acting as a person-in-plant.
Job highlights:
The head of compliance – specialty care external supply quality oversees the performance of gxp systems and procedures used by all functional units within external supplyThis individual provides strategic leadership, direction, and oversight for compliance and risk management programs and is responsible for fostering a culture of quality and continuous improvement.
Core responsibilities:
Ensure that area of responsibility is staffed, organized, and resourced to fulfill compliance obligations; provide leadership, guidance and direction to staff consistent with gxp and company quality governance
Coach and mentor staff in all aspects of their job performance and career development including training, feedback, rewards and disciplinary action
Collaborate with senior management, peers and team to routinely review/update the site quality plan and ensure priorities are aligned with business objectives
Maintain the internal quality council program, identifying risk for monitoring, mitigation, remediation and escalation according to network requirements
Maintain a network of information on regulatory intelligence to provide guidance to the site on potential impact of regulatory trends and evolutions
Establish and report applicable department or organizational metrics; monitor compliance alignment versus other sanofi network sites/organizations
Ensure a risk management program is in placer to identify, evaluate, document and communicate risks potentially impacting quality and compliance; involve a multi-disciplinary team to define remediation plans to risks impacting products and gxp operations
Maintain a site inspection readiness (ir) program and act as host during inspections performed by external functions or regulatory authorities
Interface with external regulatory authorities as required
Maintain an external network of expertise and represent the site and/or sanofi in professional organizations
Other responsibilities:
Frequent inter-departmental, inter-organizational and external interactions
Supports review and approvals of cmc dossiers, variations, renewals, annual reports, site registrations and territory extensions as needed
Basic qualifications:
Bachelor’s degree with scientific background or equivalent and 10+ years of experience
Or
Master’s degree with scientific background or equivalent and 6+ years of experience
5+ years in the biotech/pharmaceutical industry
2+ years in a supervisory role
Preferred qualifications:
Broad knowledge and experience of eu/us gmps for the biotech/pharmaceutical industry, with an understanding of worldwide regulatory requirements (e.gGmp, gdp, ich)
In-depth understanding of quality and regulatory systems and management tools
Ability to coordinate and lead diverse teams in evaluation of gxp quality systems
Problem solving, technical writing and verbal communication skills - clearly conveys information and concepts/principles
Ability to multi-task effectively
Demonstrated ability to perform work that consistently requires independent decision making and the exercise of independent judgment and discretion
Special working conditions:
Ability to travel up to 15% - primarily domestic – is required.
Ability to work up to 50% remotely
Sanofi incAnd its u.sAffiliates are equal opportunity and affirmative action employers committed to a culturally diverse workforceAll 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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At sanofi diversity and inclusion is foundational to how we operate and embedded in our core valuesWe 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 customersWe respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
