Vice President - Quality (259-419)
ARIAD is a Cambridge, Massachusetts-based biotechnology company focused on cancer. We are a cohesive team of talented people from diverse backgrounds with a shared vision: We seek to transform the lives of patients with breakthrough cancer medicines. This is our purpose. This is our passion. This is our promise.
The Vice President Quality oversees and provides strategic direction for the Quality departments. This role collaborates with the GxP (GCP, GMP and GLP) functional areas in order to facilitate quality and compliance in all GxP-related activities. The incumbent will serve as a mentor and coach to the department, modeling behaviors aligned with the company values.
Duties and Responsibilities
- Manage and oversee all GxP Quality functions globally for ARIAD, including the U.S., EU, Japan and Asia/Pacific regions.
- Maintain and develop Quality processes and competencies to drive a culture of compliance and collaboration.
- Lead the development of quality systems aligning policies, processes and procedures with internal and outsourced activities.
- Assure that product and stability testing is conducted in compliance with regulations and company policies/procedures, and that QC documents ensure traceability/accountability and are accessible.
- Support the planning, scheduling, and performing GxP audits/inspections (internal and external) to assure adherence to company SOPs, and any applicable regulatory requirements.
- Provide guidance with regard to CAPA recommendations for compliance issues and/or observations.
- Support the development of company training programs for GxP-related procedures, practices and system requirements
- Oversee formal risk assessments to determine level of compliance risk. Lead the implementation of appropriate mitigation strategies.
- Build and drive “Lean” initiatives and lead process improvements for Quality Information Management Systems and seek to implement compliant paperless enterprises.
- Remain current with quality management trends. Review and interpret new international regulations, and ensure that ARIAD quality systems evolve appropriately.
- Hire, train, mentor and manage staff as well as external consultants.
- Preparation and oversight of department operating plans and budgets.
- Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
- Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization
- MS in bio-pharma-related area; Ph.D. is a plus.
- 20+ years of pharmaceutical/biotech industry experience with increasing responsibilities, including 7+ years leading a Quality function, for both development and post-approval activities.
- Extensive knowledge of GCP, GLP, and GMP including 21 CFR 11.
- Experience in successfully supporting the transition from product development to commercial quality systems and operations
- Previous experience in establishing and/or enhancing effective development and commercial GxP quality infrastructure and systems compliant with US and international requirements.
- Proven track record in successfully establishing and managing global Quality staff (both GMP and GCP), including in the EU and Asia/Pacific region
- Direct experience with interacting with US and international regulatory authorities for pre-approval and post-approval inspections.
- Strong management and interpersonal/communication skills and the ability to deal effectively with a variety of personnel including medical, scientific, commercial and operational staff.
- Ability to lead and influence cross-functionally to ensure GxP compliance. Effective leadership, negotiation, and collaboration abilities.
- Proven ability to succeed in a fast-paced environment.
- Excellent verbal and written communication skills.
- Strong commitment to business ethics
- Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners
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ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.