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Senior Manager/ Associate Director, Supplier QA at Intarcia Therapeutics, Inc. in Hayward, CA

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Description

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.

Your Opportunity

As a key member of our diverse quality team, the Senior Manager/ AssociateDirector, Supplier QA will be the subject matter expert and support the implementation of the Supplier Qualification Program to comply with the global regulatory requirements. The candidate will be responsible for developing processes, procedures, and quality standards, in collaboration with his immediate Manager, Product Development, Supply Chain, Clinical Research, and other functions at Intarcia to establish risk-based Supplier Qualification Program. This position will serve as the key subject matter expert (SME) for Supplier Management Program and represent Intarcia QA during regulatory audits.

Duties and Responsibilities:

  • Draft SOPs for Supplier selection, management and qualification of all external vendors, contract manufacturing organizations (CMO's), contract research organizations (CRO's) and service providers (i.e., maintenance, calibration and test laboratories).
  • Develop a supplier audit schedule, generate audit plans and conduct quality audits for GMP suppliers, CMO, and service providers.
  • Negotiate and draft quality agreements with all critical suppliers, CMO's and service providers.
  • Manage product quality complaints, quality incidents, Supplier Corrective Action Requests (SCAR), and CAPA associated with materials and/or services provided by our suppliers and initiate Supplier Corrective Action.
  • Manage Supplier change notifications and Supplier change requests to ensure that changes are recorded, communicated to the appropriate stakeholders and addressed appropriately.
  • Provide technical support for analytical test method development and for process development for device components and other materials used in the manufacture of our drug products.
  • Maintain the Approved Vendor list for Intarcia.
  • Participate in the Material Specification Committee Board to review and approve Material Specifications.
  • Ensure that controlled copies of specifications are communicated to Vendors and work with them to ensure that changes are properly assessed and incorporated in Vendor quality system if necessary.
  • Maintain Supplier vigilance including KPI's to ensure the suitability of materials for compliance with specifications and regulations.
  • Maintain Vendor files and conduct periodic assessment of files to ensure all certification documents, licenses, and statements are current and comply with current regulations and standards.
  • Maintain Vendor audit reports, audit responses, and pertinent corrective actions, follow-up for audits conducted in support of the supplier qualification program.
  • Create key quality metrics for tracking and trending data related to supplier audits, agreements, supplier incidents, and report metrics including significant quality incidents to QA management.
  • Conduct gap assessments in support of the supplier qualification program and inspection readiness preparations.
  • Presenting Intarcia's supplier qualification program to regulatory agencies and interacting with regulatory agencies during inspections on supplier QA related matters.
  • Manage other QA responsibilities to support GCP and GMP functions, as assigned by the Supervisor.

Qualifications/Experience:

  • A minimum Bachelor's degree in a scientific discipline is required. An advanced degree is preferred.
  • A minimum of 10 years' experience with extensive knowledge and experience in managing supplier quality assurance groups in highly regulated pharmaceutical environments.
  • Experienced and certified quality auditor with proven track record in negotiating quality agreements, hosting internal audits and conducting various types of supplier audits (i.e., raw material suppliers, contract manufacturing organizations and Service providers etc.).
  • Strong working knowledge of regulations (21 CFR Part 210, 211, 820, Part 11, ICH regulations, ISO 13485 etc.) is required.
  • Proven track record and experience in representing supplier qualification program to the global regulatory agencies.
  • Pro-active in identifying opportunities along with strong problem solving and negotiation skills.
  • Hands on execution of all aspects of supplier quality assurance functions in in an entrepreneurial, fast paced environment.
  • Strong leadership ability, interpersonal, communication, and influencing skills required.
  • 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 (Microsoft Excel, Word, Visio, MS Project and PowerPoint) are required.
  • Must be able to travel (15 - 40%)

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