Ad, Gfe Compliance Enablement Ridgefield

2 weeks ago

Ridgefield, United States BI Pharmaceuticals, Inc. Full time

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

**Duties & Responsibilities**:

- Understands and assesses all GxP compliance risks associated with the work and assets of GFE.
- Creates understanding of those risks and works with those responsible to mitigate those risks to an acceptable level.
- Drives solutions-based discussions with stakeholders in GFE and business to reduce risk/optimize work practices.
- Leads compliance support team.
- Leads validation/qualification program for computerized equipment, facilities, utilities, pilot plant equipment and environmental controlled units.
- Acts as validation manager and change owner in support of validation life cycle.
- Acts as SME for supporting systems i.e., GOTRACK and document management systems.
- Leads team of validation engineers.
- Drives compliance culture within GFE as well as upskilling of organization, directing internal and external resources.
- Responsible for Quality Management Review/compliance overview for GFE Ridgefield including the development and reporting of relevant KPIs.
- Responsible for designing and implementing programs to achieve continuous improvement of KPIs.
- Leads GxP compliance activities including management of events/deviations, CAPAs, audits, training, SOP implementation/authorship, and good compliance practices.
- Supports compliance enablement across GFE in these areas.
- Primary GFE contact for all GxP regulatory audits, GxP compliance initiatives/intercompany CAPAs, and primary point of contact for Regional Head of GFE Compliance Enablement.
- Leads and manages GFE training programs.
- Responsible for designing training programs and curricula for GFE Ridgefield personnel designed to improve technical, compliance, and behavior skills of the Department.

**Requirements**:

- Bachelor’s degree in GFE related topic or business administration with seven-plus (7+) years of experience.
- Master's degree with five-plus (5+) years of experience preferred.
- Minimum five (5) years of experience in GxP pharmaceutical facility with experience in engineering/facilities compliance management.
- Deep knowledge of FDA and GxP requirements for Pharmaceutical Development (GLP) and Manufacturing (GMP) from the engineering/facilities perspective.
- Compliance management system development experience.
- Validation/Qualification experience.
- Excellent attention to detail.
- Demonstrated ability to build and maintain relationships across stakeholder groups. Project management experience. People management experience.**Eligibility Requirements**:

- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and post-offer physical (if required).
- Must be 18 years of age or older.

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