We are looking for a Principal Compliance Consultant to provide consulting services to the Life Science industry. This is a remote position with 25% travel to client sites as needed.

Responsibilities

• This position requires expert knowledge in the design, deployment, and maintenance of Quality Management Systems as they relate to the pharmaceutical, biotech and medical device industries.
• The candidate must have a thorough understanding of domestic (US FDA) and international (Europena and Asian) GxP regulatory compliance requirements across multiple product lines (e.g., drugs, biologics, medical devices, combination, cell and gene therapy) including deep understanding of current ICH best practices documents and expectations.
• This position will be responsible for designing and executing sophisticated and complex projects for our clients in the regulated life science industry focused on developing and installing inspection readiness programs, developing and executing remediation programs, designing and installing GxP quality management systems, performing due diligence assessments of products and organizations, and planning and managing organizational change.
• This position will lead teams of multi-specialized SME’s consisting of both Pharmatech employees and Independent Contractors engaged to complete all aspects of the defined project.
• This position will have key customer interface requirements to create the project design, gain customer acceptance of the project, keep customers technically informed as the project is in execution, and create and deliver all final reporting documents required to successfully close the project.
• In larger projects, this position may provide overall project management or support another resource in their project management role.
• Support Business Development as necessary, to represent Regulatory Compliance sphere capabilities as part of bringing in new clients and projects
• Provide input into project proposals including staff and expense cost breakdowns
• Maintain current proficiency in newly introduced global GxP concepts, practices, and procedures within the regulated life sciences industry

• Develop strategies and implementation plans for design or scale-up of Quality Management Systems for pharmaceutical, biotech and Medical Device manufacturing processes
• Provide QMS expertise to diagnose gaps and develop compliance remediation approaches in response to 483 citations, Complete Response Letters, Warning letters and Consent Decrees

Qualifications

• Bachelors degree in engineering or life sciences, plus a minimum 15 years experience in creating, managing and administering Quality Management Systems for FDA regulated products is required. Minimum of 2-5 years in a consulting role is required.
• Candidates must be capable of applying diversified knowledge of compliance, regulatory, and technical principles.
• Candidate must be highly experienced in performing a wide range of regulatory compliance services for multiple product types and dosage forms
• Must possess the following attributes,
  • Strong written and oral communications
  • Strong project management skills
  • Excellent technical writing skills
• Candidate must possess essential knowledge of QRM, QbD, and QMS frameworks:
  • Risk Assessment Tools such as FMEA, HACCP, RRF, HAZOP, FTA, and PHAs
  • Quality Target Product Profile
  • Critical Quality Attributes
  • Critical Process Parameters
  • Sampling theories and plans for all aspects of development, production and release
  • Basic understanding of statistical analysis of process data
  • Excellent understanding of quality risk management programs
  • Root cause analysis methodologies
  • Phase-appropriate application of GMPs for manufacturing, testing and distributing clinical products
  • QMS frameworks for a variety of organizations (e.g., virtual, CDMO) and compliance disciplines (e.g., GDP, cGMP, GLP, GCP, GPVP)
  • Organizational change management methodologies such as AKDAR, Kotter, 7S
• Candidate must have the ability to:
  • Prepare compliance related technical documents for regulatory filings or product launches.
  • Prepare and deliver polished presentations both at industry events and to client management teams
  • Successfully negotiate through conflict to a successful and desired outcome
  • Influence others to work towards a common goal
  • Work proficiently in Microsoft 365 products (e.g. Office applications, Teams, Planner, Visio)
  • Demonstrate knowledge and deep understanding in multiple regulatory compliance areas (e.g., GDP, cGMP, GLP, GCP, GPVP).
  • Stay current and develop working knowledge of new and emerging therapeutic technologies as they relate to quality and compliance requirements including Antibody-Drug Conjugates (ADCs), stem cell, gene therapy, personalized medicine, and mRNA therapeutics

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.