Manager/Senior Manager, Quality Assurance Lot Release
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 will be primarily responsible for performing directly, or managing through QA associates, QA Product Lot Release (US and EU) and Shop Floor Compliance activities.
Duties and Responsibilities:
- Independently perform and/or manage lot release activities for raw materials, product intermediates, and final product for both clinical and commercial production.
- Support all quality assurance responsibilities associated with facility certification, manufacturing and testing.
- Review and approve SOPs, Forms, master and executed production batch records (product and media fills), specifications. Responsibilities may include review and approval of other QS records i.e., Deviations, Product complaints, CAPA, and Change Control etc.
- Partner with other functions i.e., Product Development, Regulatory Affairs, Clinical Research, Facilities and Manufacturing to meet project and product demands.
- Author and revise quality management systems procedures as required to maintain a state of compliance with cGMP (US and EU) regulations.
- Compile, track quality metrics for key quality attributes and report to management on a quarterly basis (i.e., Lot disposition, First Time Right, Batch Errors, Rejection Rate).
- Maintain the QA database for Product Genealogy, Lot Release and other KPIs as needed.
- Support QA staff to perform line clearance including facility walkthrough and product surveillance.
- Keep management apprised on key deliverables and promptly escalate quality issues to management.
- Contribute and support inspection readiness and commercial readiness preparations.
- Organize and conduct training events related to Intarcia quality procedures, cGMP regulations and guidelines.
- Ensures that the quality assurance programs and procedures are adhered and followed to ensure compliance to cGMP regulations and ICH guidelines.
- Represent QA on various projects.
- Manage other QA responsibilities as assigned by the Management.
- A minimum Bachelor’s degree in a scientific discipline is required. An advanced degree is preferred.
- A minimum of 10 years in the drug/device pharmaceutical industry and 8 years in QA managing GxP functions preferably for combination aseptic products involving all phases of clinical study (Phase I to III & commercial). Aseptic experience is preferred.
- Proven track record of releasing final finished drug product for the US and EU market.
- Strong working knowledge of cGMP regulations (for e.g., 21CFR4, 21CFR211, 21CFR820, ISO13485), and ICH guidance.
- Attention to detail in review of GMP records e.g., batch records, specifications, analytical, EM data, CoA etc.
- Pro-active in identifying opportunities along with strong problem solving and negotiation skills.
- 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.