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Associate Director of Quality Assurance

Company: Advanced Clinical
Location: Berkeley
Posted on: January 16, 2022

Job Description:

Overview

We are currently searching for a skilled professional to join a well-known client's team as a remote Associate Director of Quality Assurance out of Lexington, Massachusetts. This role will oversee the clinical-stage GMP QA operations, and support project teams in coordinating, preparing, and submitting Investigational New Drug and Biologics License Application filings with authorities. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

Responsibilities
Maintain QA and cGMP compliance for all aspects of the program to support clinical studies
Write, review, approve, and maintain cGMP documentation for preclinical functions such as SOPs, protocols, and technical reports
Establish and oversee SOPs for Pre-clinical, and clinical functions on site
Supervise execution of Quality Systems such as Change Control, complaint investigations deviation management, and risk assessment
Assist cGMP inspections of contract manufacturing and contract testing laboratories and monitor to ensure cGMP/GLP compliance
Develop, negotiate, and maintain Quality Agreements with contract manufacturing partners and ensure requirements are met/enforced
Interact with in-house personnel, contract manufacturing, and test facilities to monitor quality aspects of production and testing activities
Direct batch record review and lot disposition activities to ensure release of lots within prescribed timelines and in compliance with applicable regulatory submissions and approvals
Support equipment, utility, and facility qualification activities
Approve analytical method validations and process/product validation strategy/protocols and reports
Participate in the preparation and review of some sections of regulatory submissions
Support external and internal audits as required

Experience
Minimum of 5 years in Quality Assurance required, Biologics field preferred
Working knowledge and technical understanding of the manufacture and testing of biologics required
Experience in reviewing cGMP/GLP related documents (SOPs, protocols, batch records, technical reports
Comprehensive knowledge of cGMP principles with respect to FDA and EMA regulations desired
Experience working with contract manufacturing and testing facilities
Ability to work independently and with various work groups
Strong attention to detail and excellent organization
Excellent communication and interpersonal skills

EDUCATION
Minimum of Bachelor's Degree or equivalent in a scientific related field with a minimum of 7 years' experience in the Pharmaceutical/Biotech Industry

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.

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Keywords: Advanced Clinical, Berkeley , Associate Director of Quality Assurance, Executive , Berkeley, California

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