Be an early applicantLess than 25 applicants

Company

BridgeBio · 3 days ago

SVP, Quality Assurance

Remote - United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$330K/yr - $425K/yr

15+ years exp

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BiotechnologyHealth Care

Growth Opportunities

H1B Sponsor Likely

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Responsibilities

Overall responsibility for the development and implementation of the vision and strategy, as well as the budget for the quality function

Manage existing high-performing Quality organization and its capabilities, including providing mentorship and professional development coaching

Develop and oversee the implementation of comprehensive GXP quality assurance strategies to ensure compliance with regulatory requirements, industry standards, and company policies

Provide support to the GCP and GMP quality leaders, fostering a culture of excellence, accountability, and continuous improvement

Establish and manage an internal program for quality and regulatory inspections and audits

Ensure PAI and BIMO inspection readiness, as well as QA support of post-approval pharmacovigilance systems

Oversee the design, implementation, and maintenance of robust quality management systems, including document control, deviation management, CAPA (Corrective and Preventive Action), and change control

Lead regulatory inspections, audits, and quality assessments, ensuring readiness and compliance with FDA, EMA, and other regulatory agencies

Drive quality risk management initiatives, identifying and mitigating potential risks to product quality, patient safety, and regulatory compliance

Collaborate with cross-functional teams, including Research & Development (e.g. clinical development, clinical operations), manufacturing, supply chain, and regulatory affairs, to ensure alignment and integration of quality assurance processes throughout the product lifecycle

Provide strategic guidance and support for product quality issues, deviations, investigations, and recalls, as needed

Stay abreast of evolving regulations, industry trends, and best practices in quality assurance and proactively implement necessary changes to maintain compliance and drive continuous improvement

Foster a culture of quality and compliance throughout the organization, promoting awareness, training, and engagement at all levels

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Quality AssuranceGXP ComplianceRegulatory InspectionsQuality Risk ManagementContinuous ImprovementLeadership ExperiencePharmacy DegreeChemistry DegreeBiology DegreeICH Guidelines

Required

Bachelor's degree in pharmacy, chemistry, biology, or related scientific field

Minimum of 15 years of progressive experience in quality assurance roles within the pharmaceutical industry, with at least 5 years in a senior leadership position

In-depth knowledge of GXP, ICH (International Council for Harmonisation) guidelines, and other relevant regulatory requirements

Proven track record of successfully leading quality assurance teams and driving continuous improvement initiatives in a pharmaceutical manufacturing environment

Strong understanding of quality risk management principles

Excellent leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively across functions and levels of the organization

Demonstrated experience in leading regulatory inspections (including PAI and BIMO inspections) and interacting with regulatory agencies

Strategic thinker with the ability to develop and execute comprehensive quality assurance strategies aligned with business objectives

Detail-oriented, analytical mindset with a commitment to accuracy, integrity, and excellence in all aspects of quality assurance

Ability to travel regularly

Preferred

Advanced degree (e.g., Master's or PhD)

Benefits

Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)

Flexible PTO

Access to learning and development resources to help you get in the best professional shape of your life

Rapid career advancement for strong performers

Commitment to Diversity, Equity & Inclusion

Company

BridgeBio

BridgeBio focuses on the development and commercialization of precision medicines for various genetic diseases and cancers.

Founded in 2015

Palo Alto, California, USA

201-500 employees

http://bridgebio.com

H1B Sponsorship

BridgeBio has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (2)

2022 (3)

2021 (1)

2020 (3)