Associate Director Compliance

SUMMARY:

The Associate Director, Compliance works within the Quality Assurance department and is responsible for overseeing Compliance, the Ridgefield Internal Audit Program, Inspection Readiness, GMP Training Program, Site Change Control Program as well as the Site Risk Management Program.

JOB RESPONSIBILITIES

Compliance

· Coordinate and manage Regulatory and Sanofi GQA inspections

· Coordinate, mange and develope Regulatory Agency inspection response plans

· Oversee the timely closure of GQA and external audit responses and CAPA

· Manage Site Internal Audit program

· Oversee the site Data Integrity Program

· Manage Site Inspection Readiness

· Perform routine site Walk-thru inspection readiness inspections

· Lead and support Quality Compliance programs (e.g. Data Integrity Plan, Quality

Plan, etc.)

· Lead and support initiatives for alignment to new regulatory requirements (e.g. EU

MDR, MDSAP)

· Coordinate gap analysis and implementation activities for the Corporate Quality

Standards, Directives, and Global Operating Procedures including monitoring

progress with status reports and metrics

· Manage the Site Regulatory Intelligence communication process and Global

Response Team site responses

Training

· Oversee the site GMP Training program including creation and execution of Annual Site Training plan

·Support the creation of site training plans for significant projects (e.g. product

technical transfers) by working with cross-functional teams

· Manage the Learning Management System (LMS) to ensure training requirements

are defined in curricula and assigned to employees. Troubleshoot LMS issues

· Compile and report learning metrics

· Facilitate new hire GMP orientation, Annual GMP Refresher training, Train-the-

Trainer training sessions and other instructor led training sessions as identified

· Identify available training material from internal or external sources (i.e. computer-

based learning, instructor led materials, job aids, supplier videos) and create training

material as needed

· Coordinate periodic reviews of employee learning plans and curricula

· Lead and support Quality Culture initiatives (e.g. World Quality Week, site newsletter

articles/contests) to encourage a Quality Mindset and patient focus

Quality ·

• Lead and support the Site Change Control Program ·
• Lead and support the Site Risk Management Program ·
• Maintain Site Risk Profile Report ·
• Review/Approve changes to site documentation (batch records, test methods, protocols/reports, etc.) as necessary

Leadership Qualifications:

The Associate Director Compliance is expected to act on and demonstrate the Sanofi LEAD competencies and provide 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: ·

• Respect 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. ·
• Act honestly and treat people with respect and courtesy. ·
• Constantly strive to make Sanofi a great place to work and a company respected for the quality of its people and products. ·
• Act as a role model for our fellow employees by acting responsibly, fairly, and honestly in dealings and exercising sound judgment. ·
• Effectively communicate with individuals and within groups. Able to express ideas and thoughts clearly. Also understands that communication goes both ways: listens well and conveys a sense of openness and non-judgment
• Effectively operate in an evolving, complex, and dynamic environment, and continuously looking internally and externally for best practices and areas for improvement. ·
• Perform as a versatile learner who is comfortable with complexity and ambiguity and a courageous decision maker who is candid and direct.

HSE ·

• It is required that individuals care for their own safety and wellbeing. Individuals must promote a safe working environment for employees and contractors working in their area of responsibility. ·
• The individual must support all Sanofi and site HSE policies as well as ensure that work performed is compliant with local HSE regulations. ·
• Individuals must complete all required HSE trainings. Everyone is required to report all accidents and incidents and support investigations in their areas of responsibility. Individuals must ensure timely closure of HSE actions owned by their departments.

REQUIREMENTS:

• · Bachelor’s degree in science or engineeri