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!

Job Responsibilities:

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

Requirements:

• 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!

http://hire.jobvite.com/j/?cj=oLThXfwC&s=Mass_Biotech_Council