Executive Director, Quality Control Operations
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.
The candidate is responsible for developing and managing all aspects of the Quality Control Operations function for commercial drug/device combination aseptic products. The candidate is responsible for managing and overseeing Analytical, Microbiology and Environmental laboratory functions including external QC service providers. Responsibilities include strategy, vision, planning, implementation, and day-to-day operations of the Quality Control unit.
The candidate will have direct responsibility for managing all Quality Control Operations in Hayward and oversee all testing activities performed at contract testing laboratories and service providers.
Duties and Responsibilities:
- Oversee and direct a technical QC team that is responsible for all aspects of the Quality Control function including, but not limited to, testing of raw materials, drug substance, intermediates, finished product lot release and stability.
- Provide strategic leadership in order to develop commercial quality systems that are cGMP compliant and ensure that the department remains current with compendial requirements and global regulatory expectations.
- Implement best laboratory practices for testing commercial products.
- Build and implement a strong commercial QC organization to manage analytical and microbial testing including oversight of external test laboratories. Hold the team accountable for preparing and achievable tactical goals.
- Provide guidance and technical expertise to QC personnel and the team in all areas of Quality Control functions, including finished product and drug substance lot release testing and stability testing.
- Compile quarterly management report on key KPI’s (i.e., OOS/OOT, and Stability) for API, raw materials, intermediates and drug product.
- Identify, assess and communicate QC strategies, KPI metrics, gaps and compliance risks to senior management on a periodic basis.
- Compile technical reports for quality controls functions on an as needed basis (Method Transfer, Validation, Technical and Supplier audit reports).
- Direct resources that will execute method transfers and validation/qualifications of laboratory equipment, and methods, as required.
- Partner with Technical Operations (Manufacturing, MSAT, Supply Chain, Product Development, Regulatory Affairs, and other functions of the Quality Organization) to drive corporate objectives and ensure that the site operates and complies with all quality, regulatory and compliance requirements.
- Ensure that the QC operations (internal and external) are inspection ready at all times.
- Serve as the QC Technical lead representing Quality Control Operations during regulatory audits i.e., US FDA, EU, State Food and Drug including partner audits.
- Support RA in writing CMC sections (for both DS and DP) related to analytical for submissions including responding to agency queries.
- Support the Supplier Quality group to conduct audits of external test laboratories, service providers and vendors.
- Prepare accurate budget and headcount forecasts for Quality Control Operations and Oversee the organization within allotted budget and headcount.
- Provide training, development and growth opportunities for employees.
- A minimum master’s degree in a chemistry and/or scientific discipline is required.
- Seasoned professional in GMP Quality Control Operations (QA and QC) for drug/device combination aseptic products with direct leadership, management and oversight of commercial test laboratories (Analytical, Micro and EM).
- Thorough understanding and knowledge of cGMP regulations (21CFR210, 211, EU Directives and Guidelines, EU Annex 1) and ICH guidance’s (i.e., Q7, Q9. Q10).
- A minimum experience of 20+ years in the drug/device pharmaceutical and biopharmaceutical industry with multiple areas of functional and technical expertise. Proven track record managing commercial laboratories is highly desirable.
- A minimum of 12 years in senior management positions leading Quality Control Operations functions either in small and/or big pharma managing commercial QC operations.
- Ability to work independently on technical and quality projects initiatives with minimum supervision.
- Demonstrated ability to solve complex quality control problems through effective and supportive relationships with colleagues and subordinates and across departments.
- Self-motivated and team player with strong leadership, administrative, interpersonal, and team-building skills.
- Strong verbal, written communication, negotiation and computer skills are required. Must be goal-oriented, quality-conscientious, and customer-focused.