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Manager/ Senior Manager, Commercial QC Change Management 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 memeber of the Quality Control team, the Manager/Senior Manager, Commercial QC Change Managementwill report into the Director, Commercial QC Compliance and will be responsible to deploy and maintain the change control management process within the commercial QC organization to effectively ensure the timely initiation and closure of change applications in a compliant manner. The Manager/Sr. Manager, Commercial QC Change Management will also be responsible to support APR/PQR preparation/submission and author/revise technical registration documents and submissions to regulatory agencies.

Duties and Responsibilities:
* Responsible for driving the initiation and progress of Commercial QC change management. Supports the Director, Commercial QC Compliance by effectively aligning with the various Commercial QC managers to ensure initiation and closure of change applications in a timely manner.
* Supports Director, Commercial QC Compliance, as needed, in representing the commercial QC organization at site Change Management Board meetings and disseminates information back to team members.
* Drives changes through change control process and ensures timely execution per commitments. Escalates to QC stakeholders as needed.
* Tracks metrics/KPI for change control closure rates.
* Ensures conformance to all regulatory requirements, including those of the FDA and various international regulatory bodies.
* Interacts during GMP inspections with regulatory inspectors on QC change control issues.
* Supports APR/PQR preparation and submission
* Authors and revises technical registration documents and submissions to regulatory agencies. Partners and aligns with QC stakeholders on content of submissions.
* Supports the Director, Commercial QC Compliance by partnering with Regulatory Affairs and QA Change Control to address documentation with regulatory submissions.
* Assists with the review of drug product release testing data to support QA release.
* Manages multiple projects, set priorities, and work in a fast-paced environment.
* Able to negotiate, influence, and work in a matrix environment.

Qualifications/Experience:
* A minimum B.S. degree in a scientific discipline is required. An advanced degree is preferred.
* A minimum of 6-8 years of experience in a commercial QC laboratory operation or QA with focus on change management and QC regulatory submissions
* A minimum 2 years management experience in commercial QC laboratories/matrix organization with strong understanding of QC systems related to change management
* Strong working knowledge of GMP regulations and pharmacopeia requirements
* Experience in interacting with regulatory agencies, supporting GMP and PAI inspections.
* 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.
* Experience in managing projects desired.

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