ProPharma Group

Senior Compliance & Quality Assurance Consultant

ProPharma Group • $90K — $130K *
Western Springs, IL 60558In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
1 week ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific discipline required; graduate degree preferred.
  • Minimum of 10 years in quality assurance and regulatory/GxP compliance.
  • Strong preference for 3 or more years managing a technology business or serving as a CQA SME lead.
  • Recent experience leading audits, with at least 5 audits performed per year.
  • Ideal candidates will have QC laboratory experience, preferably in chemistry/analytical.

Responsibilities

  • Act as a Subject Matter Expert (SME) in quality assurance and regulatory/GxP.
  • Manage projects within the CQA business practice independently.
  • Ensure project profitability and monitor personnel performance.
  • Maintain up-to-date knowledge of regulatory and technological changes.
  • Contribute to risk-based GxP project implementations effectively.
  • Engage in the sales process to outline project scope and requirements.
  • Support marketing efforts through presentations and social media content.

Benefits

  • Remote working support with an emphasis on hybrid collaboration.
  • Professional development opportunities in quality assurance and regulatory consulting.
  • Emphasis on continual improvement regarding customer satisfaction.
  • Exposure to a range of clients and GxP issues in the industry.
Full Job Description
  • Primarily responsible for representing the company as a Subject Matter Expert (SME) in assigned areas of quality assurance and regulatory/GxP. Responsible for providing independent consultation and management of projects within the CQA business practice.
  • Support the execution of the strategy for their respective CQA service line. This includes ensuring profitability of projects, and as applicable, the monitoring of performance of current personnel executing assigned projects.
  • 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.
  • 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 a SME and identify scope and effort required to successfully address client needs.
  • Support marketing efforts by promoting CQA services through presentations and development of social media content and blogs.
  • Promote continual improvement regarding customer satisfaction with emphasis on CQA consulting services.
  • 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. Provide consultation for the implementation of proper CAPA to resolve deviations and non-conformances. Also, to ensure compliance of company operations to quality principles and participation in the development of quality systems through SOP writing and training.
  • 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.
  • Other duties as assigned


Required Skills / Abilities
  • Strong knowledge of applicable US FDA, ICH, EMA, MHRA regulations and guidance documents.
  • High-level expertise in GxP systems and capable of providing independent consultation based on previous experience and system knowledge.
  • Ability to earn and maintain a client's confidence through appropriate planning, organizing, controlling, and directing 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 manage and execute multiple tasks within the compliance, quality assurance, and relevant Life Science 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.


Education / Experience Requirements
  • 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 10 years relevant experience in quality assurance and regulatory/GxP compliance.
  • Minimum 3 years managing a technology business or business unit or CQA SME lead 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. Candidate's Audit Log should reflect at least 5 audits performed per year.
  • Strong preference for candidates with experience working in a QC laboratory, preferably in a chemistry/analytical lab.


#LI-EB3

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.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

About ProPharma Group

ProPharma Group is a pharmaceutical consulting company that provides regulatory compliance, pharmacovigilance, and medical information services to clients in the healthcare industry. The company was founded in 2001 and is headquartered in Shawnee Mission, Kansas. ProPharma Group offers a range of services, including clinical trial support, quality assurance, and validation services. The company has worked with clients in a variety of industries, including pharmaceuticals, biotechnology, and medical devices.
Learn more about ProPharma Group
Size
500 employees
Industry
Pharmaceuticals & Biotech
Net Income
$5 million
Founded
2001
5 Year Trend
+30%
Revenue
$50 million
* Ladders Estimates

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