Sr. Manager / Associate Director, Quality Assurance

Pliant Therapeutics is a clinical 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 for progress to meet unmet medical needs for patients and physicians.  The company’s focus is on mechanism-based intervention in the fibrotic process using small molecules. The company’s lead product candidate, PLN-74809, is designed to be a selective inhibitor of αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration in both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC), has completed Phase 1b testing. Pliant’s second product candidate, PLN-1474, is designed to be an oral, small molecule selective inhibitor of αvβ1, targeting late-stage liver fibrosis and is partnered with Novartis.  The Company is seeking passionate, creative and dedicated individuals to join our team and contribute to our mission.

Description

The ideal candidate will have extensive experience managing cGMP aspects of Quality Systems, Quality Operations, and deep understanding and demonstrated working knowledge of Code of Federal Regulations (CFRs), ICH guidance documents, and other regulations that govern GxP compliance during clinical development of drug candidates.  This includes Quality oversight of GxP computerized systems and software validation, training, product disposition, and management of CMO/CTL activities related to manufacturing and testing of Pliant drug substance, bulk drug product, and packaged/labeled drug product for clinical trials.

Essential Functions

  • Review and approve change controls (CMO and internal) associated with validated computer systems, manufacturing, and testing of clinical products. Responsible for performing impact assessment of proposed changes.
  • Review and approve SOPs, Mater Batch Records, test methods, test results, labeling materials, specifications, analytical validation protocols and reports, and stability protocols and reports and associated records/data.
  • Perform oversight review and batch disposition of drug substance, bulk drug product and packaged/labeled drug product to be used in clinical studies and as applicable distribution. Review and approve records, including associated change controls, investigations (deviations, out-of-specification/out-of-trend), and analytical data.
  • Establish and maintain phase-appropriate procedures and processes that will effectively support cGMP activities during the various phases of drug development.
  • Review and approve Contract Manufacturing Organization (CMO) or Contract Testing Laboratory (CTL) investigations (deviations, out-of-specification/out-of-trend, complaints).
  • Perform internal annual audits as applicable.
  • Conduct trainings as needed for Quality owned systems.
  • Manage and trend product complaints.
  • Track, monitor, and generate Quality metrics for Management Reviews.
  • Apply the principles of ICH Q8 (Pharmaceutical Development) and Q9 (Risk Management) to the development of manufacturing processes. Ensure a systematic approach to development with pre-defined objectives and emphasizes product and process understanding and process control based on sound science and quality risk management.
  • Support departmental functions and build partnerships and collaborate with applicable stakeholders in other areas of the business to ensure success of the Quality Operations and continuous process improvements.
  • Support the organization in maintaining a work environment focused on quality and one that fosters learning, respect, open communication, collaboration, integration, and teamwork.
  • Represent QA on product development teams as applicable and assigned.

Requirements

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, and/or ability required.

  • Experience with batch disposition and review of analytical-related documents (test method and stability protocols and reports) is strongly preferred
  • In-depth knowledge of ICH guidelines related to stability (Q1A-Q1F), Analytical Validation (Q2), and Specifications (Q6A-Q6B)
  • Comprehensive working knowledge of local, state, federal, and international regulatory compliance pertaining to GMP, and European manufacturing requirements
  • Prior experience participating in or hosting regulatory inspections
  • Must be able to maintain compliance perspective necessary to meet deliverables and deadlines
  • Ability to make appropriate risk-based assessments and decisions based on phase-specific GMP requirements
  • In-depth knowledge and experience implementing phase appropriate procedures and processes related to QA Operations
  • Experience with interacting with domestic and international CMOs for early phase to late stage clinical trials
  • Strong and clear understanding of cGMPs and pharmaceutical industry best quality practices
  • Demonstrated leadership in cross-functional and culturally diverse team settings
  • Travel as needed

Preferred Education/Experience:

  • Bachelor’s degree in a scientific discipline
  • 15+ years of hands on experience in the pharmaceutical or biotechnology industry, with specific experience in GMP Quality Assurance, CMO oversight, auditing and Quality Systems
  • Experience in either a GMP manufacturing or Quality Control testing role is a plus
  • Knowledgeable in validation of computerized systems, software, and 21 CFR Part 11 Electronic Records, EU Annex 11 and Electronic Signatures
  • Understand and able to interpret regulatory authority regulations, guidelines and policies. Communicate and ensure compliance with Quality objectives, policies and procedures and escalate to Sr. Management as appropriate

Knowledge, Skills and Abilities:

  • Results and goals oriented
  • Able to work collaboratively in a matrix structure while ensuring that timelines and deliverables are met
  • Excellent verbal, written, interpersonal, organizational, and communication skills are necessary with the ability to influence individual and teams across the organization in the absence of a direct reporting relationship
  • Ability to work independently with minimal guidance
  • Ability to build and manage relationships with business partners
  • Accuracy and attention to detail
  • Excellent cross-functional team collaboration skills
  • Ability to grasp new technologies
  • Ability to work under deadline pressure, and to effectively prioritize and manage multiple projects (multi-task) and rapidly shifting priorities in a very fast-paced environment
  • Solution oriented with analytical thinking and problem-solving skills