Location:  This position can be located in Florham Park, NJ or Wyandotte, MI

Ideal Candidate:

5+ to 7 years of experience
Management Experience Required – No
Minimum Education – Bachelor’s Degree
Willingness to Travel – Occasionally

Seeking an individual to be part of the Product Regulatory Center of Expertise Team, who provides EHS support through a North American shared services platform.  In addition, this position will be part of the Global Product Safety and Regulatory Affairs Team.

This position is primarily responsible for indirect food contact assessments and support for assigned North American and Global Business Groups.

 The successful candidate will work closely with Product Regulations/Product Stewardship and Business Product and Technical Management to:

Actively contribute to the Global Regulatory Affairs Team as a regional team member.

Assess products for assigned North American businesses and targeted European businesses to determine status under US and Canadian Food Contact Law; coordinate and manage data according to existing processes.

Coordinate Food Contact Notifications under US FDA requirements and Letters of No Objection from Health Canada and act as the technical contact with the agencies.

Implement / Maintain food contact governance program for assigned North American businesses.

Provide expertise in European and Asia Pacific food contact requirements via network with European and Asian colleagues to support North American businesses.

Provide food contact regulatory expertise; interpretation and impact determination for assigned North American businesses.

Support customer requests as necessary.

In cooperation with Product Regulations team, ensure SAP system (BASIS) is maintained accurately.

Track regulatory developments of assigned North American product regulations.

Determine applicability of new/revised food contact regulations and issue communications to affected North American community

Provide strategic and tactical consultation to Business Group management and Product Stewardship regarding food contact compliance issues and opportunities.

Support the development, implementation and maintenance of food contact regulatory compliance programs.

Develop and/or deliver food contact training for North America community.

Lead or support food contact nonconformance investigation and reporting.

 Position travel:  approximately 15% travel

REQUIRED:

The successful candidate will possess the following Qualifications:

BS Engineering, Sciences (BS Chemistry Degree preferred)

Minimum 5 years of demonstrated experience in a regulatory, manufacturing, and/or lab environment

Demonstrated regulatory knowledge U.S. FDA and Canadian Food Contact is required

Demonstrated FCN and Letters of No Objection registration experience is required

Experience implementing regulatory compliance processes and programs

Experience with Regional and Global Business and Functional organizations is preferred

Knowledge of products and substances manufactured,imported and the IT systems that are used to govern them (i.e., SAP, Ariel, Decernis, etc.)

Ability to work independently on multiple, concurrent and variable assignments is essential

 DESIRED:

European and/or Asia Pacific food contact knowledge preferred

SAP (BASIS-EHS Module) Computer skills preferred

Knowledge of Spanish and/or German is useful

Location:  Indianapolis, IN

The Ideal Candidate:

5+ to 7 years of experience

Management Experience Required – Yes

Minimum Education –Master’s Degree

 Willingness to Travel – Occasionally

The Clinical Trial Support Operations (CTSO) team is responsible for providing clinical trial study drug management services and supporting the Demand Management side of the business by providing the following support services:  Distribution, Study Order Management and Ownership, and Business Systems Support & Operations. The Clinical Trial Support Operations team partners with appropriate business partners to ensure study order ownership and support to successfully enable clinical research.

The Director is responsible for developing and implementing the strategy for the Clinical Trial Support Operations department, effectively managing the capacity and capabilities of the organization, ensuring strong cross functional partnerships exist in support of the portfolio, and overseeing compliant business processes and deliverables that lead to the on time delivery of Investigational Products that enable Clinical Research.  The Director provides appropriate oversight to ensure full compliance with GxP, corporate standards/policies/procedures, operational excellence, continuous improvement, personnel development and overall leadership.

KEY OBJECTIVES/DELIVERABLES:

Execute all position responsibilities in a way that integrates ethics and compliance and follows all applicable regulations, the Corporate Integrity Agreement, The Red Book, and policies related to job content.

Management

• Accountable for the global business operation process and execution of the CTSO group
• Provide leadership, direction and oversight for -50 people in Indianapolis, Indiana and Brussels, Belgium
• Organize the department so as to reach the fixed objectives.  Recruit the necessary employees and ensure their training.  Foster the development of technical and organizational expertise.  Forecast adequate budgets and manage the department accordingly.
• Ensure that CT material is produced and supplied on time and in compliance with the quality standards and regulatory requirements (FDA, EMEA, ICH)
• Ensure the appropriate facilities, buildings and equipment are available
• Develop effective relationships with the customers and business partners
• Accountable for delivery of information and services to support the global clinical development strategy.
• Drive continuous process improvement and increased efficiency
• Accountable for all aspects quality and compliance
• Effectively manage all communication channels
• Anticipate and resolve issues with the organization and key stake-holders
• Accountable for operational leadership and excellence
• Accountable for development and communication of objectives as well as execution against the objectives
• Accountable for ensuring development of operations skills and capabilities.
• Accountable for implementation and utilization of all supply chain management principles and practices.
• Strategy
• Develop the Vision and associated strategy and plans to successfully deliver all CTSO responsibilities
• Responsible for contributing to and leading the organization to deliver the CTMS vision and strategy.
• Foster and support continuous process improvements
• Support all aspects of the CTMS transformation agenda

External Focus

• Maintain and foster contacts with the other global functions in Indianapolis and ELECTS (CTMM, outsourcing, packaging, quality, manufacturing, etc.)
• Create relationships with customers and external organizations or other pharmaceutical companies (benchmarking).
• Leverage the academic environment to foster innovation.
• Promote the participation of employees in external activities, congresses, seminars that will allow them to exchange professional information.
• Actively manages relationships with external business partners to ensure a positive and productive working environment and enable a FIPNET working environment 
• Provide an external focus through appropriate interaction with other departments; seek to understand trends in the CT supply business.

MINIMUM REQUIREMENTS:

B.S. in Scientific, Operations or related field with 7-10 years experience in pharmaceutical drug development with expertise in at least 1 of the following areas: Product Research and Development (PR & D), Manufacturing, Clinical and 5-7 years experience in people management

OR

Advanced degree (e.g., PhD, PharmD, M.S. Management, MBA) with 5-7 years experience in pharmaceutical drug development with expertise in at least 1 of the following areas: Product Research and Development (PR & D), Manufacturing, Clinical and 3-5 years experience in people management

Location: Boston, MA

Ideal Candidate:
5+ to 7 years of experience
Management Experience Required – No
Minimum Education – Bachelor’s Degree

Willingness to Travel – Occasionally

The company is looking for a Clinical Quality Assurance Manager to perform and manage internal, client and vendor audits; write, edit and manage Quality System documentation; provide training to internal staff; manage the CAPA process; develop and report on quality metrics; and provide input on industry best practices.

Specific Responsibilities:

-Develop and maintain quality management system documentation, including documents specific to regulatory and compliance processes and procedures
-Oversee internal training, including regulatory and compliance training of study personnel
-Perform audits of internal processes and procedures to ensure staff compliance
-Perform quality audits of external vendors and partners to evaluate prospective groups and review ongoing work under contract
-Perform audits of project procedures, training, documentation and records
-Develop and implement quality programs including training personnel to ensure compliance with practices and procedures in support of company- wide quality programs such as ISO certification
-Ensure compliance of procedures with applicable regulations
-Manage the CAPA process to address findings, issues and non-compliances from both internal and client audits, working with other groups as applicable
-Host client audits of our company, including presentation of our company’s Quality Management System and responding to questions
-Deliver trainings as required on QMS processes and procedures
-Maintain internal training records and ensure timely compliance with company and job specific training requirements
-Develop, maintain and report on quality metrics related to compliance, training effectiveness and resolution of issues including CAPAs and audit findings
-Provide in-house guidance on the application of national, regional and local laws and regulations (e.g., privacy, data protection, ethics) to project-specific requirements and ensuring compliance

Qualifications:
-Minimum of 4+ years of experience in the Quality field within the life sciences industry
-Knowledge of relevant healthcare regulatory environment standards and regulations, for example GCP, FDA, ICH, other organizations
-Experience working in a structured environment
-Experience performing process and documentation audits
-Experience developing process documentation
-Proven ability to address and resolve non-compliances
-Ability to develop training programs and successfully train personnel
-Ability to prioritize and schedule time for various activities such as audits considering business needs
-Ability to organize and track documentation and records
-Ability to understand and interpret national, regional and local regulations related to our company’s work
-Bachelor’s degree, preferred in scientific or health-related discipline