Director, Quality Assurance
EPIRUS Biopharmaceuticals (NASDAQ: EPRS ) is building a global biosimilar enterprise to improve patient access to important medicines. EPIRUS is developing a broad portfolio of biosimilar monoclonal antibodies, currently focused in immunology and oncology. The Company’s strategy for commercial success relies on tailored approaches to address the diversity of target global markets. Lead asset BOW015 (biosimilar to reference biologic Remicade®) has been extensively characterized, with positive PK/PD and Phase III safety and efficacy clinical data, supporting marketing approval in India. Epirus is actively progressing applications for marketing approval for BOW015 in additional global markets and is planning an additional Phase III trial in Europe in early 2015. Additional current pipeline assets include adalimumab (biosimilar to reference biologic Humira®) and bevacizumab (biosimilar to reference biologic Avastin®).
Director, Quality Assurance at Epirus Biopharmaceuticals will establish Quality policies, standards and Quality Management Systems to ensure global GxP compliance through all phases of product development by Epirus, a virtual biosimilar product development company. The Director, QA will provide strategic and operational leadership for Quality Systems and GxP procedures required to ensure manufacture and supply of high quality biosimilar products for clinical trials and to support technology transfer to Epirus’ licensees. The incumbent, in collaboration with Epirus’s licensees, will develop and drive plans to implement the licensee site specific GxP compliant Quality systems and procedures along with Epirus’s SCALE™ Manufacturing platform processes in In Market For Market Territories. He/she would ensure effective QA collaborations with process development, manufacturing, regulatory and program management teams and support Epirus’s goals for biosimilar product development.
- Establish GxP compliant Quality Policies, Standards and Quality Management System for Epirus’s internal needs and for GxP compliance oversight on outsourced development (non-clinical, clinical), manufacturing and supply through all phases of biosimilar product development
- Ensure GxP compliance of internal and outsourced Quality Management practices and procedures
- Champion implementation of ICH guidelines
- Develop and implement supplier qualification and quality management programs. Ensure pool of qualified supplier for GxP compliant products and services consistent with Epirus’s biosimilar product development programs
- Development and implementation of Quality Management Review programs driving high level of GxP compliance internally at Epirus and at suppliers of services and products for human use
- Experience with management of Quality Control laboratory operations.
- Drive successful collaborations with Epirus’s CMOs, CROs, GXP compliant service providers and licensees
- Provide leadership and directions for transfer of Quality Systems and procedures consistent with SCALE™ Manufacturing and Supply Processes to Licensee sites
- In collaboration with Licensees ensure GMP compliance through all phases of In Market For Market manufacturing and supply facilities design, construction, commissioning, qualification and validation
- Lead a team engaged in sourcing GxP compliant product suppliers and GLP, GCP and GMP service providers
- Knowledge of GCP compliance requirements and experience with management of clinical Quality Assurance
- Identify and engage personnel required for Quality Assurance and GxP compliance management
- Develop and manage the QA department budget
- Set goals for continuous improvements in QA and GxP compliance driving product quality improvements
- Set goals an manage to accomplish QA goals in support of corporate goals
REQUIREMENTS & QUALIFICATIONS
- Demonstrated ability to collaboratively lead a team in a dynamic and fast moving organization.
- Excellent written, verbal communication, presentation and facilitation skills Additional languages a plus, but not required.
- Ability to plan and prioritize concurrent and conflicting projects
- A high level of leadership in Quality and Compliance regulatory requirements and ability assess risk drive decisions through diverse challenges while maintaining high level of quality and compliance.
- A bachelor’s or master’s degree in science with 12+ years of experience in Quality Control and Quality Assurance in biopharmaceutical company/ies with a minimum of 5 years at the level of Associate Director or above.
- Experience with development and implementation of Quality policies, standards and procedures in a both a startup setting as well for established Contract Manufacturers
- Strong knowledge of ICH guidelines and world-wide GxP requirements
- Demonstrated success with performance improvements in the level of GxP compliance, e.g., leading regulatory inspections – Pre- and Post-approval, dealing with 483s, addressing compliance deficiencies at CROs and CMOs
- Experience of working with CMC teams through all phases of biopharmaceutical product development
- Experience with GMP compliant manufacturing facility construction, commissioning and qualifications
- Experience with preparation of IND, IMPD, CTA, MAA, BLA type dossiers for regulatory review and approval
- Experience with CMOs and commercial supply chains for biopharmaceutical products
- The following personal characteristics:
- Action-oriented, combined with high ethical standards.
- A self-starter with a high energy level.
- Self-confidence combined with humility in approach.
- Compassion and passion for patients.
- An ability and willingness to take controlled risks.
- A willingness and desire to be a team player.
- Culturally sensitive.