Director, Quality Assurance (Drug Substance) South San Francisco, CA at Pliantrx

Director, Quality Assurance (Drug Substance)

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

The successful candidate will be responsible for Quality Operations, providing strategic leadership including phase-appropriate oversight of internal and external activities. He/she will provide effective Quality oversight of manufacturing and Quality Control (QC) operations for early through late-phase clinical development program, including client facing interactions, supporting supplier qualification and inspection readiness. This position reports to the Senior Director of Quality Assurance (GMP/GLP). The Director is a subject matter expert in GMP regulations and will ensure compliance to applicable regulatory standards, industry best-practices and internal procedures as well as identify and lead continuous Quality improvement initiatives.

This role will provide oversight of drug substance contract service providers (CSPs), develop and review quality agreements, lead batch disposition activities and support future commercialization. The candidate should have strong hands-on experience with developing, implementing, maintaining, and improving Quality System procedures using risk-based principles to ensure adherence to regulatory and Pliant requirements.

This is a hybrid position, requiring 3 days/week at Pliant (South San Francisco).

Responsibilities

• Responsible for the disposition of drug substance, including review of master and executed batch records, specifications, certificates of analysis and analytical test data (in-process and release) for manufacturing and testing conducted at CSPs.
• Review and approve validation protocols/reports (e.g., process, method), analytical test methods, reference standard, stability protocols/reports and establishment of retest date.
• Support commercialization activities, including process validation and technology transfer.
• Support the development, implementation, and enhancement of Quality Systems including disposition, vendor management, deviations, change control and CAPA.
• Perform review and closure of internal and CSP generated deviations (including OOS and OOT), change controls, and CAPAs, ensuring timely escalation and notification to leadership and compliant resolution of product-impacting quality issues.
• Establish and ensure adherence to batch-related metrics, effectively communicate status, and provide strategic recommendations and improvement actions to Senior Management.
• Participate in Quality Management meetings such as Material Review Board and Quality Management Review.
• Contribute to development and revision of Quality Agreements.
• Collaborate on supplier qualification and management including supplier audits, as needed.
• Participate in internal and external inspection readiness and inspection activities.
• Contribute to CMC sections of regulatory submissions as necessary.
• Build and foster a quality mindset within Quality and throughout the company by ensuring consistent, risk-based process are employed in decision making.

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.

• 12+ years’ experience required with a BS/BA degree in a scientific discipline or 10+ years’ experience with a MS degree.
• At least 10+ years of pharmaceutical or biotechnology industry cGMP experience including 5+ years of experience in positions of management responsibility within Quality Assurance.
• Strong knowledge of cGMP, ICH, FDA, and EU regulations.
• Direct experience working with CSPs within the US and globally to meet disposition timelines.
• Prior global commercial experience, including process validation and technology transfer.
• Exercise sound judgement in ensuring that written procedures are followed with proven ability to drive quality process improvement initiatives.
• Highly collaborative team player who fosters open communication and facilitates cooperation between stakeholders.
• Excellent written and oral communication skills with the demonstrated ability to communicate with internal and external team members clearly and concisely.
• Strong technical acumen with proven leadership capabilities and prior experience leading direct reports.
• Available to travel domestically and internationally when needed.
• Small company / pre-commercial to commercialization stage experience.
• Small molecule and solid dosage experience. Biologics experience is a plus.
• Applies a solutions-oriented mindset and approach to resolving complex quality issues.
• Effective strategic leader and ability to mentor and develop team members.
• High self-awareness and commitment to iterative learning and development.
• Strong analytical, problem-solving, and decision-making capabilities.
• Must demonstrate high organizational, prioritization and management proficiencies.

Pliant requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

The annual base salary for this role is $225K – $235K. 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.