Associate Director, GxP Computer Validation Program Management
Pliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar to meet the unmet medical needs of physicians, patients and families impacted by fibrotic diseases. As the leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, Pliant is developing small molecule drug candidates specifically designed to impact the fibrotic process.
The Company’s lead product candidate, bexotegrast (PLN-74809), is an oral small molecule, selective inhibitor of the αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration for both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant is currently conducting BEACON-IPF, a Phase 2b/3 trial of bexotegrast for the treatment of IPF.
Pliant is conducting a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. The Company also has discovery and development programs in oncology and muscular dystrophies.
Description
Pliant Therapeutics is currently seeking a seasoned industry leader to join our team as Associate Director, GxP Computer System Validation Program Management, reporting to the Senior Director of Quality Systems and . This role will provide strong leadership and strategic planning in support of client functions within the organization.
To be successful in this role, you must be able to establish vision and guidance to the GxP personnel, communicate clearly (in verbal and written form), and display exemplary organizational / leadership skills. This will require the ability to develop and administer quality systems in regards to GxP Computer Validation Program Management, including electronic quality system processes utilizing phase appropriate principles. In addition, the successful candidate will create an environment in which the team is highly motivated and engaged to work collaboratively within their team and cross functionally to deliver exceptional results and ensure long-term success.
This is a hybrid position, requiring 3 days/week at Pliant (South San Francisco).
Responsibilities
- Oversee and/or assists in the development of validation deliverables including Validation Plans, Test Plans/Protocols/Scripts, Specifications and Design Documents, Compliance Assessments, Risk Assessments, Installation Qualification, System and User Acceptance Testing, Data Migration Plans, Traceability Matrices, Validation Reports, Supplier Assessments, etc..
- Provide technical expertise to define approaches and execution of system validation activities in accordance with GxP, CFR Part 11, and other applicable regulations or procedures.
- Ensure GxP document deliverables are in compliance with site and corporate policies and procedures following risk-based lifecycle approach from user and business requirements development through system retirements.
- Work with project teams to select methods and techniques for obtaining desirable solutions for each GxP project and work with Quality Assurance to ensure compliance with regulations.
- Work closely with business stakeholders, technical support groups including vendors, and Quality Assurance to thoroughly investigate validation discrepancies, and drive remediation for system validation.
- Maintain the controlled GxP computerized system inventory, identify deficiencies in the validation status and prioritize remedial actions based on risk.
- Support assessment of third-party/vendor compliance to Pliant GxP Computer Validation standards; participate in vendor audits and identify deficiencies to ensure validation deliverables are in compliance with site and corporate policies and procedures.
- Lead process improvement efforts of computerized system policies, procedures and computerized system validation processes.
- Manage the Software Development Lifecycle (SDLC)and Change Control processes, using standard procedures for documenting business-lead, IT projects. The objective is prompt and efficient handling of changes to systems, reducing impact on the business and maintaining compliance with industry regulations.
- Work closely with IT to develop and implement internal control and procedures that will enable the business to stay compliant with regulated requirements including but not limited to GxP.
- Assist and support for internal auditors and external auditors during scheduled IT audits.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.
- Bachelor’s degree in a scientific discipline required
- Minimum 10 years’ experience with at least 7 years of experience in computer system validation with increasing responsibilities and 5 years of recent experience in a pharmaceutical manufacturing environment.
- Knowledge of GxP, FDA, and EU regulations including 21 CFR Part 11, Risk-driven System Development Life Cycle (SDLC) methodologies, and change management processes.
- Strong technical understanding of computer system design, architecture, implementation, integration, and IT infrastructure.
- Must demonstrate working knowledge of business risks and internal controls and procedures, including Internal Audit and compliance
- Ability to work effectively with minimal supervision.
- Ability to communicate complex topics in simple terms to any audience.
- Excellent teamwork and collaboration skills.
- Excellent planning and project management skills.
- Understanding of the requirements of computer system validation in a regulated pharmaceutical environment (Part 11 compliance and risk-based approach).
- Strong technical background in computer systems, such as architecture, design, implementation, integration, or support.
- Ability to communicate effectively within cross-functional teams.
- Strong planning, organization, and communication skills.
- Detail oriented with the ability to identify gaps and propose solutions.
- Experience working in a GxP environment.
- Excellent interpersonal, written, and verbal communication skills required.
The annual base salary for this role is $180K – $190K. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant’s compensation package also includes benefits, equity, and annual target bonus for fulltime positions.
To understand how Pliant complies with and manages your personal information with respect to the California Consumer Privacy Act, please visit https://pliantrx.com/ccpa-applicant-and-staff-privacy-notice/.
