ProPharma Group

GCP Compliance & QA Consultant.

ProPharma Group • $90K — $120K *
Western Springs, IL 60558In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
5 days ago
Job Overview by Ladders

Qualifications

  • 5+ years of experience in quality assurance and GxP compliance.
  • Bachelor's degree in a scientific discipline; a graduate degree (MSc/PhD) is preferred.
  • Knowledge of US FDA, ICH, EMA, and MHRA regulations.
  • Recent auditing experience with at least 5 audits performed in the last year for applicable roles.
  • Eligibility as a Qualified Person (QP) or Responsible Person (RP) when applicable.

Responsibilities

  • Represent the company in quality assurance and GxP areas.
  • Manage CQA project consultations and support project management.
  • Stay updated on regulatory changes and develop subject matter expertise.
  • Execute GxP projects with a risk-based approach.
  • Engage in the sales process to identify client needs and scope.
  • Support marketing by creating content promoting CQA services.
  • Provide client training on CQA consulting services.

Benefits

  • Support for hybrid working arrangements.
  • Opportunities for personal and professional development.
  • Exposure to a variety of projects in the Quality and Compliance Consulting field.
Full Job Description
Essential Functions:
  • 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.


Necessary Skills and Abilities:
  • 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 and one other European language preferred (for EU employees).
  • 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.


Educational Requirements:
  • Bachelor's degree, or similar college degree, in a scientific discipline as a minimum
  • A graduate degree (MSc / PhD) in a scientific discipline is preferred.
  • As applicable, eligible to be registered as a Qualified Person (QP), Responsible Person (RP) and Responsible Person import (RPi).


Experience Requirements:
  • Minimum 5 years relevant experience in quality assurance and regulatory / GxP compliance
  • As applicable, previous registration as a Qualified Person
  • 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).


#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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