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Associate Director, GCP Quality Assurance

Company: Advanced Clinical
Location: Mountain View
Posted on: October 13, 2020

Job Description:

OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as an Associate Director, GCP Quality Assurance in Mountain View, California. The Associate Director, GCP Quality Assurance role will serve as a subject matter expert and ensure all systems, processes, and their outcomes are compliant with Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP) guidelines. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES

* Analyze and interpret updates to GCP regulations to assure best Clinical/QA practices

* Organize, prepare, coordinate, and document regulatory inspections

* Evaluate and qualify CRO's and other GLP/GCP pharmacovigilance service providers

* Communicate audit findings to audit stakeholders

* Ensure understanding to link appropriate implementation of Corrective and Preventive Action Plans (CAPAs) and address root causes

* Review and approve audit plan, audit observations, and assess the adequacy of CAPAs

* Prepare, coordinate, and manage regulatory agency inspections

* Develop, review, and update QA SOPs for GLP/GCP compliance

* Schedule and conduct GLP and/or GCP Audits of systems and processes related to preclinical/clinical operations and pharmacovigilance

* Oversee internal/external systems and processes for GLP/GCP compliance

* Input and review clinical documentation (protocols, study reports, IB)

* Identify, escalate, and resolve quality and compliance issues in a timely manner

* Contribute to process improvement initiatives across the organization

EXPERIENCE

* Minimum of 8 years of relevant pharmaceutical industry experience in GCP/clinical quality assurance required

* Minimum of 5 years of Good Clinical Practices (GLP/GCP) auditing experience

* Global Clinical QA experience desired

* Knowledge of Phase 1-4 clinical trials, clinical investigator site audits, and vendor audits

* Detailed knowledge and interpretation of FDA/EU and ICH - GLP/GCP regulations and guidelines

* Experience with regulatory authority inspections, including both FDA and EMA inspections

* Excellent interpersonal and communication skills

* Strong computer skills, including all MS Office applications

* Ability to assume significant project management skills

* Strong written and verbal skills to write reports, presentations, and email correspondence

* Travel required - up to 30%

EDUCATION

* Minimum of Bachelor's Degree in Life Sciences required

* Advanced Degree preferred

To be a best-fit your strengths must include:

* Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.

* Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.

* Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.

* Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.

* Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.

* Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.

About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

Keywords: Advanced Clinical, Mountain View , Associate Director, GCP Quality Assurance, Executive , Mountain View, California

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