Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Cambridge, Massachusetts
We are currently searching for a skilled professional to join a well-known client's team as Principal QA GLP Auditor in Cambridge, Massachusetts. The onsite Principal QA GLP Auditor role will administer, manage, and execute GLP quality activities and ensure that appropriate processes and procedures are compliant with regulatory requirements, company policies, and business needs. Their work will have a direct impact on the organization and also on the larger clinical industry, making this an amazing career opportunity
* Plan, conduct, and manage GLP inspections/audits of Contract Research Organizations and Laboratories to ensure compliance with health authority regulations and guidelines, site SOPs, protocols, and industry standards
* Assist in the development of corrective and preventive action when appropriate and ensure effective reporting mechanisms are developed and followed
* Establish performance criteria, monitor results, coach, and develop knowledge and competencies of team members involved in GLP inspections
* Develop, optimize, and promote continuous quality improvement activities, policies, and SOPs
* Identify training needs of personnel engaged in the conduct of the GLP studies
* Design and conduct training plan and maintain training records and supporting documentation
* Participate in other quality assurance work
* Maintain knowledge of current quality and GLP practices, literature, applicable professional regulations, and theories in field of expertise
* Collaborate and interact with others in a mutually supportive and cooperative manner
* Minimum of 8 years of quality systems experience with at least 4 years in a GLP QA management role with responsibility for overall GLP quality operations required
* Experience in managing GLP inspections conducted by regulatory authorities
* Advanced understanding of the application of OECD and FDA principles of GLP
* Demonstrated leadership abilities, including the ability to motivate, coach, and develop employees
* Excellent English verbal and written communication skills
* Knowledge of various dosage forms and/or delivery systems
* QA experience in other quality systems desired
* Experience with developing and conducting employee training
* Excellent technical writing and problem-solving skills
* Travel required - domestically 20 to 40%
* Minimum of Bachelor's Degree in in Chemistry, Chemical Sciences, Biochemistry or equivalent required
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 identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, disability, 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.