Quality Recruiting. Established Experts.

Director of Internal Process & Technology Compliance

Reference Number: 2855
Location: MA

Our client is an international biopharmaceutical company.  They have asked us to assist them in their search for a Director of Internal Process & Technology Compliance.

Under the direction of the Head of R&D QA and Compliance (R&D QA&C), this position is responsible for providing the strategic direction and compliance leadership for the Internal Process and Technology Compliance Center of Excellence (CoE) of R&D QA&C.  Primary responsibilities for this role are to lead the internal process audit program for R&D, lead the audit strategy and compliance support for R&D computerized systems, represent R&D QA&C on due diligence assessments (in-license and M&A), and to represent R&D QA&C on R&D integration projects of acquired firms.  Primary duties include, but are not limited to, liaising with various internal R&D functions and stakeholders; providing strategic leadership to the Internal Process and Technology Compliance CoE team; setting the audit strategy for R&D internal processes, R&D computerized systems, and external vendors providing R&D computer system applications or eServices (EDC, IXRS, ePRO); collaborating with the Business Development function and R&D teams to assess product or company opportunities through the due diligence process; and delivering the integration of R&D QA&C related personnel, processes, and systems of acquired companies.

Major tasks and responsibilities will include:

  • Leads the development and execution of the R&D internal process audit program by ensuring a long-term risk-based audit schedule is maintained, indicated audits are included on the R&D QA&C Master Audit Plan (MAP), the prescribed audits are executed and reported on time, and audit responses/CAPAs are adequate to foster continuous improvement of R&D processes.
  • Identifies potential systemic gaps and coordinates with the appropriate stakeholder to ensure timely remediation.
  • As appropriate, escalates issues of critical non- compliance and/or lack of urgency in remediation to senior management.
  • Facilitates the development of process audit trending and outcome interpretation for management.
  • Provides leadership and line management to the R&D QA&C Internal Process Audit Lead.
  • Defines and implements the strategy for R&D technology and systems compliance.
  • Serves in an advisory/consultative role in R&D Computer System Validation (CSV) compliance related matters.
  • Maintains the Master Validation Plan (MVP) for GxP regulated R&D systems.
  • Guides team in support of R&D IT implementation or upgrade projects requiring quality review/approval of validation deliverables and/or auditing of service providers.
  • Ensures that R&D systems are maintained in a state of control via change management process and the conduct of system periodic reviews.
  • Verifies that CAPAs from audits are adequate and implemented as promised.
  • Promotes inspection readiness with a culture of sustainable compliance through training and advising stakeholders.
  • Provides leadership and line management to the R&D QA&C Technology Compliance Leads.
  • Represents R&D QA&C on R&D due diligence teams to assess in-licensing and acquisition opportunities.
  • Focuses assessments on identifying compliance risks with development programs and/or target company operations.
  • Identifies and coordinates SMEs in R&D QA&C for support and provides training and guidance as necessary.
  • Reviews materials on electronic reading rooms and/or onsite away team visits at target company and/or vendors.
  • Compiles assessment outcome into R&D section of due diligence report.
  • Represents R&D QA&C on R&D integration projects for acquired companies.
  • As required, leads R&D QA&C integration sub-team.
  • Leads a team consistent with expectations.
  • Provides strategic direction and tactical oversight for all elements of team responsibility.
  • Ensures every employee knows what is expected of them, what it takes to be successful, and how they are progressing.  Holds everyone accountable to achieve results.  Provide guidance in the setting of team and individual goals in alignment with R&D and R&D QA&C goals.
  • Helps employees continually grow through challenging opportunities so they can realize their potential.
  • Serves as a member of the R&D QA&C Leadership Team to influence the operations and future strategy of the R&D QA&C function.
  • Develops and manages the strategies for the preparation, hosting and responses to regulatory agency inspections as applicable to the CoE including participation in hosting and management of inspections as required.

We seek candidates with the following qualifications:

  • Bachelor’s degree in a life science or technical discipline required; Master’s Degree in management or scientific discipline preferred.
  • At least 10 years of pharmaceutical/biotech quality experience.
  • Ideal candidate will have broad experience in R&D product development, strong knowledge of R&D applicable GxPs including applicable CSV standards (ISO, GAMP, etc.) and regulatory requirements, experience with managing and conducting audits within the R&D functional areas, thorough understanding of CSV requirements, background with regulatory agency inspections, and at least 5 years of management experience – specifically direct reports.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2855. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.