|This position will oversee the development of Progenics’ all GxP (GMP, GCP, and GLP) functional areas, ensuring quality oversight and compliance in all GxP related efforts, with particular emphasis on supporting a successful pre-approval inspection and commercial launch in 2018 of the Company’s lead asset, AZEDRA.
Duties and Responsibilities:
- Oversee and manage all Quality functions
- Ensure that Quality processes and competencies in paticular GxP quality are in place to drive a culture of compliance and collaboration
- Lead preparedness for and conduct of health authority inspections. Establish and maintain positive relationship with FDA and other regulatory authorities.
- Lead the development of pharmaceutical quality systems – aligning policies, processes and procedures with internal and outsourced activities
- Assure that manufacturing activities and product testing are appropriate, are conducted in compliance with company policies and procedures, and that documentation is accessible and ensures traceability/accountability
- Ensure that Quality Agreements are complete, approved and updated at appropriate intervals
- Support planning, scheduling and performing GxP audits/inspections (internal and external) to assure adherence to company SOPs and any applicable regulatory requirements
- Oversee risk assessments to determine level of compliance risk. Lead implementation of appropriate risk mitigation strategies
- Provide guidance for investigations as well as corrective and preventive action (CAPA) plans for compliance issues and/or observations
- Support development of company training programs for GxP-related procedures, practices and system requirements
- Manage process improvements for quality information management system
- Remain current with quality management trends. Review and interpret new regulations, and ensure that Progenics’ quality systems evolve accordingly
- Prepare and manage department operating plans and budgets
- Oversee hiring of staff as well as external consultants
- Recruit, train and mentor staff
- Perform other duties as required
- Bachelor’s degree in biopharma or related field. Advanced degree in related area preferred
- Must have a minimum of  years of experience in pharmaceutical/biotech industry with increasing responsibilities, including 5+ years leading a Quality function for both development and post-approval activities
- Experience overseeing product approval (NDA or BLA) essential; i.e., transition from product development to commercial quality systems and operations
- Experience establishing and/or enhancing development and commercial GxP quality infrastructure and systems compliant with U.S. and international requirements. Successful track record managing U.S. and international pre- and post-approval inspections
- Extensive knowledge of GMP, GCP and GLP including 21 CFR Part 11
- Proven track record in establishing and managing GMP/GCP Quality staff
- Expert knowledge of quality risk assessment and management methodologies, including successful application and risk remediation
- Strategic thinker, able to integrate complex business considerations in formulating a quality approach
- Strong management and interpersonal/communication skills. Prior success in working effectively with senior scientific, medical, commercial and operations staff
- Approximately 10% domestic and some international travel
|Technical Skills Required:
|· Strong written and verbal communication skills.
· Detail oriented and possess strong analytical and problem solving skills.
· Self-motivated with strong organizational and leadership abilities.
· Results oriented with a demonstrated track record of meeting deadlines and responding to the urgent needs of the organization while working on multiple projects.
· Possess in-depth knowledge of US, EU and international GCP guidelines and regulatory requirements