Merrimack is a biopharmaceutical company based in Cambridge, Massachusetts that is outthinking cancer to ensure that patients and their families live fulfilling lives. Our mission is to transform cancer care through the smart design and development of targeted solutions based on the deep understanding of cancer pathways and biological markers. For more information, please visit Merrimack's website at www.merrimack.com or connect on Twitter at @MerrimackPharma.
We are looking for a highly motivated professional to lead our Quality Assurance (QA) team. Investigational products are manufactured and QC tested by CMOs and released to the clinic by Merrimack QA. QA is also responsible for performing or commissioning GXP audit activities, including GCP for clinical trials - which are sponsored by Merrimack and conducted globally with CROs.
- Oversee development and continuous improvement of company's quality assurance and compliance functions, including oversight of GXP training.
- Plan and organize personnel and workflow to implement the timely QA review, approval and release of products in accordance with applicable internal quality system policies, procedures and external regulations and standards that govern the products manufactured, labeled, tested, stored and 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.
- Provide regular updates and recommendation to the company senior management with regard to the status of such objectives, projects and goals as relate to compliance status
- 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, etc., as necessary.
- Ensure internal and external audit program is adequately defined and followed (inclusive of comprehensive CAPA development, approval and execution)
- Provide QA subject matter expert (SME) support for business activities
- Define and approve departmental budget and capital expenditures
- Exercise independent action in QA personnel management, motivation and development within established company policy and procedures
Qualifications / Skills Required:
- Minimum BS (Chemistry, Biology or related Life Sciences)
- Minimum 10 years of quality systems experience, including leadership, in biotech/pharmaceuticals
- Experience in managing and leading direct reports
- Experience of FDA audit
- Background that includes knowledge/experience in GMP, GLP, GCLP and GCP
- Background in biotechnology and/or liposomal drugs a definite asset
- Experience in global QS and international QA management would be an asset
- A passion for fighting cancer