Vice President of Quality Assurance
Merrimack Pharmaceuticals is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of serious diseases, with an initial focus on cancer. Merrimack applies Network Biology, its proprietary systems biology-based approach to biomedical research, throughout the research and development process. Merrimack currently has six targeted therapeutic oncology candidates in clinical development.
We are looking for a passionate Vice President of Quality Assurance to join our team in Cambridge!
This is the most senior level Quality Assurance position at Merrimack. The ideal candidate will oversee development and continuous improvement of organizational and programmatic elements of the company's quality assurance and compliance functions, including oversight of GXP training. Additional responsibilities include:
- Plan and organize personnel and workflow utilization in order to implement the timely QA review, approval and release of products and processes in accordance with applicable internal quality system policies, procedures and external regulations and standards that govern the products manufactured, labeled, tested, stored, promoted and/or distributed by or for the company
- Ensure compliance with applicable internal and external regulations, standards, policies and procedures related to the quality and regulatory status and performance of company operations, processes and products, including GMP, GLP, GCLP and GCP.
- Develop, implement and monitor progress against the company’s strategic quality plan, related quality objectives, projects and goals for associated departments
- Provide regular update and recommendation to the company senior management staff with regard to the status of such objectives, projects and goals as relate to business compliance objectives
- Maintain contact with critical vendors, professional organizations, consultants and peers in order to be current with prevailing industry standards
- Represent company as the primary liaison with involved external regulatory and standards bodies (e.g. the Food and Drug Administration (FDA) inspectorate, other global regulatory compliance inspectors, ISO assessors, etc.) when necessary to coordinate audits and adjudicate issues with compliance concerns.
- Ensure internal and external audit program is adequately defined and followed (inclusive of comprehensive CAPA development, approval and execution) in a manner that is both timely and global in nature
- Review and audit the validation programming and execution for manufacturing processes, test methods, software, cleaning and facilities/equipment/utilities through a comprehensive validation master plan
- Provide organizational and subject matter expert (SME) support for company acquisitions of new or existing products, processes, techniques, procedures or facilities/equipment in regards to ensuring compliance with applicable quality criteria
- Recommend QA actions or policies that result in cost reduction, efficiencies or increased profitability to the company
- Ensure that critical or strategic priorities at the site and corporate levels are afforded QA resources and sufficient quality oversight to ensure timely resolution and complete without undue concern for delay, non-conformance or non-compliance
- Define and approve departmental budget and capital expenditures
- Exercise independent action in QA personnel management, motivation and development within established company policy and procedures
- Minimum BS (Chemistry, Biology or related Life Sciences)
- Minimum 15+ years of senior quality systems leadership in biotech/pharmaceuticals
- Extensive experience of FDA audits mandatory
- Background in global QS and international QA management, including GMP, GLP, GCLP and GCP
- Background in biotechnology and/or liposomal drugs a definite asset
If you are interested in a great opportunity with a fantastic company, please click the link below to apply!
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Founded in 1985, MassBio represents over 600 biotechnology companies, academic institutions, research hospitals, and service organizations involved in life sciences and health care, and works to advance policy and promote education, while providing member programs and events, industry information, and services.
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