Lead GCP Quality Assurance Manager
2 weeks ago
JOB PURPOSE:
Accountable for enhancing, implementing, and maintaining QA frameworks and processes that support GCP and pharmacovigilance (PV) activities. Provides assistance in the organization and execution of vendor audits and related documentation tasks.
Key Responsibilities:
- Assist in the formulation of internal protocols and systems pertinent to GCP and PV QA functions;
- Offer direct support to clinical research teams and engage in QA planning and execution to streamline study operations;
- Participate in the establishment and endorsement of the CQA audit calendar, including the contracting of PV and GCP audits and conducting detailed audits;
- Develop, track, and manage reports that encompass critical Clinical and PV Compliance and QA metrics;
- Support various development teams;
- Oversee and engage in intricate audits and regulatory inspections;
- Independently address complex compliance challenges, communicate findings to management, and propose solutions;
- Educate staff and supervise GCP/PV consultants;
- Uphold policies and procedures within CQA;
- Collaborate with other departments on compliance issues and provide guidance to all audited entities;
- Stay updated on current regulatory requirements and inform Clinical Development stakeholders of potential impacts on the organization;
- Assist during external audits and inspections by regulatory authorities;
- Contribute to the design and delivery of internal GCP training;
- Represent CQA in internal presentations focused on quality challenges, initiatives, and projects.
- None
- BS/BA degree in a relevant field with a minimum of nine years of pertinent experience; or,
- MS/MA degree in a relevant field with a minimum of seven years of pertinent experience; or,
- PhD in a relevant field with a minimum of two years of pertinent experience; or,
- Equivalent combination of education and experience.
- Typically requires a minimum of six to eight (6-8) years of related CQA, GCP, PV experience, and/or a combination of experience and education/training.
- At least 6+ years of progressive related experience.
- Experience in the biotechnology or pharmaceutical sector is preferred.
- Demonstrated understanding of the drug development lifecycle.
- Proven experience in audit execution and management, particularly in GCP and PV domains;
- Familiarity with supporting preparation and submission activities, especially related to GCP and PV Quality, for global regulatory filings.
- Strong communication abilities.
- Capacity to influence and negotiate effectively within a team; strong interpersonal skills.
- Expertise in problem-solving.
- Implement innovative solutions to complex challenges;
- Detail-oriented and committed to precision in task execution.
- Proficient in Microsoft Word, Excel, PowerPoint, and Visio.
- Addresses significant and unique challenges requiring evaluation of intangibles;
- Capable of multitasking and managing complex assignments;
- Handles complex issues necessitating in-depth knowledge of clinical research and PV processes;
- Utilizes independent judgment in decision-making to achieve results;
- Contributes to the development of methods and criteria for projects and programs;
- Collaborates with various teams to ensure project objectives are met.
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