Note: The job is a remote job and is open to candidates in USA. ProPharma is a consulting firm that has been improving the health and wellness of patients for 25 years. They are seeking a GCP Compliance & QA Consultant to represent the company in quality assurance and regulatory compliance, manage projects, and support clients in GxP issues while promoting customer satisfaction and continual improvement.
Responsibilities
- Represent the company in assigned areas of quality assurance and regulatory / GxP
- Provide consultation and support the management of projects within the CQA business practice
- Keep pace with the regulatory and technological changes in the CQA field and develop subject matter expertise to take advantage of those opportunities to increase the company’s effectiveness
- Be a critical team member who contributes to the implementation and successful execution of risk-based and phase appropriate GxP projects
- Participate in the sales process as required and identify scope and effort required to successfully address client needs
- Support marketing efforts by promoting CQA services through the development of social media content and blogs
- Promote continual improvement regarding customer satisfaction with emphasis on CQA consulting services
- As applicable, provide CQA specific training to clients and associates within other business units
- Provide support to clients and all functional units of ProPharma as GxP issues such as deviations and non-conformances arise. Provides consultation for the implementation of proper CAPA to resolve deviations and non-conformances. Also, is responsible for ensuring compliance of company operations to quality principles and participation in the development of quality systems through SOP writing and training
- Directly engage with employees at all levels to educate on compliance and quality assurance to drive continuous improvement
- It is anticipated that this position will maintain a percentage of billable project work as determined on a quarterly basis
- For CQA Consultant roles that are primarily focused on auditing, recent auditing experience is required (at least 5 audits performed in the past year as reflected in the candidate’s audit log)
- The CQA Consultant in the EU or UK can function as QP / RP / RPi (as applicable) for clients
- If applicable, an eligible QP can be assigned the role of “QP for ProPharma MIA License”; whose role, responsibilities, duties, and training requirements are detailed in the separate QMS supporting the ProPharma MIA License
- Other duties as assigned
Skills
- Knowledge of applicable US FDA, ICH, EMA, MHRA regulations and guidance documents
- Expertise in GxP systems and capable of providing consultation based on previous experience and system knowledge
- Ability to earn and maintain a client's confidence through appropriate planning, organizing, controlling, and execution of a project
- Willingness and ability to travel as required
- Ability to interact in a professional and positive manner with clients and co-workers through strong interpersonal and communication skills
- Effective written and oral communication skills; ability to write, type, express or exchange ideas; ability to convey information / instructions accurately in English
- Ability to manage and execute multiple tasks within the compliance, quality assurance, and relevant Quality and Compliance Consulting services (e.g., QMS development, QA oversight, auditing, cell / gene therapies, regulatory agency action response, etc.)
- Quality orientation and high attention to detail
- Strong analytical skills
- Bachelor's degree, or similar college degree, in a scientific discipline as a minimum
- Minimum 5 years relevant experience in quality assurance and regulatory / GxP compliance
- Strong working knowledge of GxP principles including the Code of Federal Regulations (CFRs) and EU GMP / GDP regulations
- For Consultant, CQA roles that are primarily focused on auditing, minimum of 1 year experience leading audits (e.g. audit prep, running the audit, writing final report, etc.) and recent auditing experience is required (at least 5 audits performed in the past year as reflected in the candidate's audit log)
- A graduate degree (MSc / PhD) in a scientific discipline is preferred
- Ability to convey information / instructions accurately in one other European language preferred (for EU employees)
- As applicable, previous registration as a Qualified Person
Benefits
- We celebrate our differences and strive to create a workplace where each person can be their authentic self.
- We are committed to diversity, equity, and inclusion.
- 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.
- All applications to roles at ProPharma are personally reviewed by a member of our recruitment team.
- We do not rely on AI screening tools to support our hiring process.
- You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
- Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration.
- As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager.
- All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
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