48 N Middletown Rd
Manager Quality Risk and Performance - Pearl River, NY or Meriden, CT
Summary of purpose/major responsibilities
Defines, sets, deploys and maintains the Quality Risk Management (QRM) principles, processes and systems at the site and ensures the system and processes are consistent with Global Sanofi guidelines, and are efficient and effective.
Provides expertise, direction and coaching on QRM processes and tools as well as on specific issues and develops the knowledge of pro-active and reactive QRM.
Ensures the application of escalation process and appropriate communication internally and externally. Contributes to the development of a QRM mindset within the company.
Implements and maintains Quality metrics monitoring program at the site.
Monitors performance against site quality plan with follow up of quality performance, site quality reviews and all specific programs such as data integrity program
This position has a high degree of autonomy and is expected to make decisions and interpretations within broadly defined requirements.
As accountable of the Sanofi documentation alignment this position will be strongly involved in the quality integration process of PSC within Sanofi and will guarantee a good transition from a project to a routine mode.
Key accountabilities: % of time
* Defines QRM governance for the site and ensures its deployment in a consistent way. Ensure principals are appropriately trained in QRM process and consistently follow process (20%)
* Acts as QRM focal point for PSC (2 sites and CMO's) and interact with QRM community /network within Sanofi Pasteur and Sanofi and Coordinates risk assessments with the support of Sanofi Pasteur Subject Matter Experts,if necessary. (20%)
* Ensures appropriate reporting and follow up on risk mapping, remediation plan, including the escalation of critical Quality Risks (participates in CQC meetings related to critical site non-conformities). (10%)
* Implements and maintains Quality metrics monitoring program; reports globally and locally improvement/quality programs to ensure quality performance expectations are met (site quality review, site quality plan, Data integrity program for example) (20%)
* Coordinates the alignment with Global Sanofi documentation (gap assessment, remediation plan, KPi's , and tool management) (30%)
* Breadth of responsibility (global/regional/country/site): Pearl River, NY and Meriden, CT and CMO's
* Financial dimensions: This position does not have budgetary responsibility and purchasing authority.
* Headcount management : none
* The individual interacts regularly with regional counterparts on inter-site activities relating to risk management and metric preparation and reporting.
* The individual will issue monthly performance reports including defined KPIs.
* Individual should expect to participate in 3-5 CQC meeting annually.
* Position will manage a portfolio of 50 to 80 risks per year for PSC.
* A Bachelor's Degree is required (preferably in life sciences or a similar field of study).
* A minimum 10-12 years' experience in a cGMP controlled/pharmaceutical industry, including at least 5 years' experience in a regulated Quality environment with direct involvement in QRM
* Thorough knowledge of cGMPs, QRM, and regulatory requirements
* Experience interacting with regulatory agencies and health authority inspections
* Ability to coach other in QRM process.
Skills / Competencies:
* Excellent organizational, interpersonal and leadership/teamwork abilities
* A strong customer focus and ability to prioritize and adapt to business and manufacturing needs
* Must be able to work strategically in a fast paced environment and make balanced decisions related to quality.
* Diverse business, quality, and industrial manufacturing knowledge base
* The individual will transversely with other departments including Regulatory Affairs and MTech.
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.* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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