Job summary
Job post source
This job is directly from ProPharma
Job overview
The GCP Compliance & QA Consultant (GCP Auditor) role at ProPharma involves leading quality assurance projects and audits to ensure compliance in pharmaceutical, biotech, and medical device industries, impacting client success and regulatory adherence.
Responsibilities and impact
The consultant will conduct GCP, GLP, and GCLP audits, develop and manage Quality Management Systems, support regulatory responses, draft SOPs, provide compliance consulting, train clients and employees, and contribute to business growth through project scoping and client engagement.
Experience and skills
Requires a bachelor's degree in a scientific discipline (graduate preferred), over 10 years of clinical compliance and GCP auditing experience including leadership roles, proficiency in SOP writing, audit performance, and strong communication and analytical skills.
Career development
Offers opportunities to work on impactful projects, develop expertise in cutting-edge areas, and grow within a collaborative and innovative environment.
Work environment and culture
ProPharma promotes a collaborative, supportive, and inclusive culture valuing individuality, innovation, continuous learning, and employee empowerment.
Company information
ProPharma is a 20-year-old consulting firm specializing in regulatory sciences and quality compliance for biotech, pharmaceutical, and medical device sectors, providing end-to-end customizable solutions to advance scientific breakthroughs.
Job location and travel
This is a full-time remote position within the continental United States with monthly travel opportunities for project support.
Application process
Applicants are encouraged to apply directly; ProPharma does not accept resumes from third-party recruiters or agencies and requests no phone calls or emails regarding this posting.
Unique job features
The role offers remote flexibility, monthly travel, involvement in diverse audits including biologics and cell/gene therapies, and opportunities to influence quality and compliance in high-profile drug and device programs.
Company overview
ProPharma is a global leader in providing comprehensive compliance, regulatory, and quality solutions to the pharmaceutical, biotechnology, and medical device industries. They generate revenue through consulting services, helping companies navigate complex regulatory landscapes, ensuring product quality, and achieving compliance with international standards. Founded in 2001, ProPharma has grown through strategic acquisitions and global expansion, establishing a strong presence in key markets worldwide. Their expertise spans from early development through post-approval, making them a trusted partner in bringing safe and effective products to market.
How to land this job
Position your resume to highlight extensive experience in GCP, GLP, and GCLP audits, emphasizing leadership roles and successful management of complex QA projects to align with ProPharma's needs.
Focus on showcasing your skills in developing and overseeing Quality Management Systems, SOP writing, regulatory response development, and CAPA implementation to mirror the job description's technical requirements.
Apply through multiple channels including ProPharma's corporate careers page and LinkedIn job postings to maximize your application visibility and ensure you don't miss internal referral opportunities.
Connect on LinkedIn with current ProPharma employees in the quality and compliance division; use ice breakers like commenting on recent company initiatives in clinical compliance or asking about their experiences with ProPharma’s innovative consulting model.
Optimize your resume for ATS by incorporating keywords from the job description such as 'GCP auditing,' 'Quality Management Systems,' 'CAPA,' 'SOP development,' and 'clinical compliance' to increase chances of passing initial screening filters.
Leverage Jennie Johnson's Power Apply feature to automate tailored resume customization, identify all relevant application portals, and find LinkedIn contacts for networking, allowing you to focus your energy on preparing for interviews and further skill development.
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