Propharmagroup
Senior Compliance & Quality Assurance Consultant
United States · Senior
Sponsorship not specifiedDetected 30 days ago
Product ManagementAuditingClinical TrialsClinical ResearchFDA RegulatoryPharmacovigilanceResearchCommunicationPublic SpeakingGxP
About the role
- Provide consultation for the implementation of proper CAPA to resolve deviations and non-conformances.
- Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits.
- With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
Responsibilities
- Support the execution of the strategy for their respective CQA service line.
- Keep pace with the regulatory and technological changes int he CQA field and develop subject matter expertise to take advantage of those opportunities to increase the company's effectiveness.
- Support marketing efforts by promoting CQA services through presentations and development of social media content and blogs.
- Provide support to clients and all functional units of ProPharma as GxP issues such as deviations and non-conformances arise.
- It is anticipated that this position will maintain a percentage of billable work as determined on a yearly basis from the service line budget tiers.
- Strong knowledge of applicable US FDA, ICH, EMA, MHRA regulations and guidance documents.
- Ability to earn and maintain a client's confidence through appropriate planning, organizing, controlling, and directing of a project.
- Minimum 3 years managing a technology business or business unit or CQA SME lead is preferred.
Requirements
- Participate in the sales process as a SME and identify scope and effort required to successfully address client needs.
- Willingness and ability to travel as required.
- Bachelor's degree, or similar college degree in a scientific discipline as a minimum.
- Graduate degree (MSc/PhD) in a scientific discipline is preferred
- Minimum of 3 years recent experience in leading audits (e.g., audit prep, running the audit, writing the final report, etc.) is required.
Compensation
- Candidate's Audit Log should reflect at least 5 audits performed per year.
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