Associate Director/Director GCP QA
Intarcia Therapeutics, Inc., is a rapidly emerging biopharmaceutical company committed to developing innovative therapies that merge medicine with technology.
At Intarcia, we seek to transform the standard of care and improve patient outcomes in major therapeutic categories for serious chronic diseases, such as diabetes. We successfully completed our Phase 3 clinical trial program for our lead product, ITCA 650, and submitted our New Drug Application filing in the U.S. in 2016.
Additionally, we are developing a pipeline of products for our proprietary Medici Drug Delivery System™, comprised of three unique technologies: 1) A stabilization technology that allows for proteins, peptides, antibody fragments, and other highly potent small molecules to be stabilized at or above human body temperatures for up to three years or more; 2) A matchstick-sized osmotic mini-pump that is placed just under the dermal layer of skin to deliver a continuous and consistent flow of medication; and 3) A placement technology including proprietary tools designed to provide an optimal user experience.
We Are Growing
Since our 2012 round of financing, much progress has taken place at Intarcia, including significant enhancements to our world-class manufacturing facility, the opening of our new headquarters in Boston’s Innovation Center, and the diversification of expertise on our Board of Directors and Leadership Team through new senior leaders who contribute vital new capabilities and experiences.
A key element of pride during our progress has been our ability to remain fully independent throughout our rounds of financing so that we continue to have full strategic and executional control over all aspects of our rapidly evolving business. While we are always accountable to our stakeholders, we are – and intend to remain – the driving vision and force behind our progress and our ultimate success.
As a key member of the Quality Assurance department, the Associate Director/Director, GCP QA is responsible for developing and implementing GCP procedures for managing Intarcia’s clinical studies program. This individual will be the subject matter expert in GCP, develop standards and partner with Clinical Research, Contract Research Organization (CRO) and other clinical vendors to establish risk-based GCP quality systems processes and procedures. This position will serve as the key point of contact representing Intarcia GCP QA in various projects, liaising with CROs, Partners and various regulatory agencies on GCP related matters.
Duties and Responsibilities:
• Develop quality systems SOPs for GCP to manage clinical studies program for US and ROW, including oversight of GCP activities managed by Intarcia CRO’s and contracted vendors.
• Ensure clinical trials are conducted in accordance with applicable study protocols, and in compliance with GCP and ICH guidelines.
• Partner with Supply Chain, Clinical Research, Product Development, and CRO subject matter experts to identify and implement GCP procedures in compliance with GCP regulations/guidelines.
• Establish quality agreements with clinical CRO and other vendors managing Intarcia’s clinical study activities.
• Manage clinical product complaints, quality incidents and CAPA associated with GCP and clinical trial material (CTM).
• Partner with the Supply Chain to manage processes at the clinical packaging vendors, responsibilities include review and approval of master packaging records, executed batch records, specifications, investigations, CAPA, issuance of CoA for final release of the CTM and drug shipment.
• Manage GLP/GCP Audit Program for the Clinical Studies
• Develop audit plans and conduct GLP and GCP compliance audits, for e.g., Investigator sites, CRO facilities, Depots and other clinical vendors for study-specific compliance (as required).
• Create key quality metrics for tracking and trending data related to GCP activities, report metrics and significant quality incidents to QA management.
• Conduct and coordinate GCP compliance training to internal and external customers (as required).
• Lead inspection readiness preparations (internal and external) including hosting and interacting with regulatory agencies during inspections on GCP related matters.
• Manage other QA responsibilities in GLP and GMP functions, as assigned by the Supervisor.
• A minimum Bachelor’s degree in a scientific discipline is required. An advanced degree is preferred.
• A minimum of 10 years in QA managing GLP, GCP and GVP functions either in small and/or big pharma with attention to details.
• Authoring and implementing GCP procedures, reviewing clinical packaging batch records including final release of CTM for open label and double blind studies.
• Strong working knowledge of GLP, GCP and GVP regulations and IVRS is preferred.
• Managed GCP Quality functions for drug/device covering all phases of clinical study program (Phase I to III).
• Managed external vendors (e.g., CRO’s, Clinical sites, packager’s), conducted GCP audits and actively participated in regulatory inspections.
• Pro-active in identifying opportunities along with strong problem solving and negotiation skills.
• Hands on execution of all aspects of quality assurance functions in support of GCP activities in an entrepreneurial, fast paced environment.
• Leads by example and highly collaborative with the proven ability to work in a cross-functional team.
• Strong verbal, written communication skills and computer skills are required.