- Develop and maintain a strategic roadmap for Quality Assurance, Regulatory and Clinical Development aligning strategic initiatives, programs and compliance with organizational goals and industry standards.
- Engage with cross-functional leaders to understand and define quality and compliance requirements.
- Oversee the implementation, validation, and maintenance of quality systems and GxP compliant applications with agency regulated requirements.
- Coordinate with IT, QA, Regulatory and vendors to ensure that systems meet quality standards and regulatory requirements.
- Collaborate cross-functionally to qualify vendors ensuring proper process and procedures are followed.
- Act as a liaison between QA, Regulatory Affairs, IT, and other departments, ensuring effective communication and alignment of priorities and goals.
- Foster strong relationships with vendors and regulatory bodies.
- Maintain the development and enforcement of policies, standards, and procedures related to quality and compliance.
- Monitor adherence to regulatory standards including FDA, EMA, and other relevant authorities.
- Facilitate internal and external audits, ensuring readiness and compliance.
- Provide insights and quarterly reports on system performance, audit outcomes, and compliance status.
- Manage external vendors and partners to plan and communicate applications are developed, maintained, and upgraded to the highest standards, and ensuring they are kept validated and meet regulatory requirements.
- Bachelor's degree in Information Technology, Business Systems, or Computer Science or related field preferred.
- 10+ years of experience managing Clinical Development, Regulatory and QA applications and/or systems management with a focus on GxP compliance in a pharmaceutical industry.
- Strong understanding of quality systems, GxP regulations, and industry best practices.
- Strong knowledge of authoring and maintaining computer system validation documentation.
- Proven ability to manage complex projects and cross-functional teams.
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89bio San Francisco, United StatesTHE COMPANY · 89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically ...
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R&D Partners San Francisco, United StatesJob Description · Job DescriptionR&D Partners is seeking to hire a, Senior Supply Chain Analyst in San Carlos, CA.The primary function of this position is to oversee material inventory and storage and manage global material shipments through service provider and partner ecosystem ...
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BioSpace San Francisco, United StatesJob Details · Job Description · The Senior Director of GCP Clinical Quality Assurance is responsible for partnering with Clinical Operations to ensure that quality and compliance are integrated into long term strategies and day to day operations. · This role is instrumental in es ...
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Account Manager
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Veeva Systems San Francisco, United StatesVeeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth pot ...
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Nurix Therapeutics San Francisco, United StatesJob Description · The Senior Director of GCP Clinical Quality Assurance is responsible for partnering with Clinical Operations to ensure that quality and compliance are integrated into long term strategies and day to day operations. · This role is instrumental in establishing, im ...
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Clinical Pharmacology, Director
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89bio, Inc. San Francisco, United StatesTHE COMPANY · 89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically e ...
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Denali Therapeutics West Valley City, United StatesNeurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of tra ...
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Renovo Solutions San Francisco, United StatesSummary/Objective · The Business Development, Life Sciences is responsible for managing growth and development of new business while building customer relationships and providing strategic direction to help grow revenue and profit for the organization. · Essential Duties and Resp ...
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Benchling San Francisco, United StatesBiotechnology is rewriting life as we know it, from the medicines we take, to the crops we grow, the materials we wear, and the household goods that we rely on every day. But moving at the new speed of science requires better technology. · Benchling's mission is to unlock the po ...
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Benchling San Francisco, United StatesBiotechnology is rewriting life as we know it, from the medicines we take, to the crops we grow, the materials we wear, and the household goods that we rely on every day. But moving at the new speed of science requires better technology. · Benchlings mission is to unlock the pow ...
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89bio San Francisco, United StatesTHE COMPANY · 89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically e ...
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Labcorp South San Francisco, CA, United StatesMonogram, part of LabCorp's Specialty Testing Group, is seeking a Quality Analyst to join its team in South San Francisco This position will be key to Monogram's development of a sustainable and robust Companion Diagnostic (CDx) business that includes Single-Laboratory-Use assay ...
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Cytokinetics South San Francisco, United StatesCytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle p ...
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LabCorp South San Francisco, United StatesMonogram, part of LabCorp's Specialty Testing Group, is seeking a Quality Analyst to join its team in South San Francisco This position will be key to Monogram's development of a sustainable and robust Companion Diagnostic (CDx) business that includes Single-Laboratory-Use assay ...
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Cytokinetics South San Francisco, United StatesCytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle p ...
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Cytokinetics South San Francisco, United StatesCytokinetics is a late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or ...
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Cytokinetics South San Francisco, United StatesCytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle p ...
Associate Director, GxP - San Francisco, United States - Pliant Therapeutics, Inc.
Description
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.
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 and INTEGRIS-PSC, a Phase 2a trial of bexotegrast for the treatment of PSC.
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.
Description
The Associate Director, GxP & Compliance Applications will lead the strategic alignment of quality assurance, Good Practices (GxP), and regulatory compliance initiatives with business objectives.
Collaborating closely with stakeholders in Quality Assurance, Regulatory Affairs, Clinical Development, Research and Development, as well as other non-G&A Business units.
This role requires a dedicated professional with a deep understanding of the quality and compliance challenges in the biotech industry.
ResponsibilitiesTo 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.
Pliant requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).
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
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