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
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. Coordinates risk assessments with the support of Sanofi Pasteur SME’s 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 and 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%
Context of the job/major challenges:
- Must be able to work strategically in a fast paced environment and make balanced decisions related to quality.
- Must have the ability to communicate verbally and in written format effectively through multiple layers of the organization, as well as working external to the site
- Experience interacting with regulatory agencies and health authority inspections is required
- Excellent organizational, interpersonal and leadership/teamwork abilities are required
- A strong customer focus and ability to prioritize and adapt to business and manufacturing needs are required
- Strong GMP background including working knowledge of QRM tools and processes.
- Strong management and supervisory skills
- Diverse business, quality, and industrial manufacturing knowledge base
- Must be able to make balanced quality decisions.
- Must have strong leadership skills.
- The individual will transversely with other departments including Regulatory Affairs and MTech.
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.
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.
- Bachelor's Degree in life sciences or similar field of study.
- A minimum 7-10 years experience in a cGMP controlled/pharmaceutical industry, including at least 7 years experience a regulated Quality environment
- Thorough knowledge of cGMPs, QRM, risk analysis tools and regulatory requirements
- Experience interacting with regulatory agencies and health authority inspections
- Excellent organizational, interpersonal and leadership/teamwork abilities
- A strong customer focus and ability to prioritize and adapt to business needs
- Ability to coach other in Quality Risk Management process.