Senior Manager / Manager, Quality Assurance Compliance

Company Overview

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement…read on
 
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. 
 
Together we define white space, push boundaries and empower people to solve problems. If you’re someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we’ll ask “why not?” and help reengineer the future of biopharma.

What You’ll Do

This Quality Assurance Compliance Manager reports directly to the Director, QA Compliance. The position manages QA Compliance and provides global audit and compliance oversight at BridgeBio Affiliates (Cardiorenal, MLBIO, and other affiliates) and contract service providers for commercial product(s) and other applicable programs.

Responsibilities

Major Responsibilities / Accountabilities:

• Manage global Quality Agreements with external stakeholders (e.g., contract service providers), ensuring compliance with all terms and conditions, regulatory requirements, and internal standards.
• Collaborate with internal cross-functional teams and external stakeholders to bring Quality Agreements to an approvable state.
• Coordinate regulatory authority inspection readiness activities at CSP and internally.
• Participate in the global supply chain vendor qualification process to ensure compliance with regulatory and internal standards.
• Participate in the planning and conduct of internal audits, and support external audits.
• Ensure audit findings are followed up, corrective actions are completed, implemented, and verified to ensure compliance.
• Identify and assess risks to compliance, develop mitigation strategies, and ensure effective implementation.

Other Quality Assurance Compliance related responsibilities:

• Support the development of meaningful quality metric reports or dashboards related to inspections or audits.
• Participate in hosting regulatory inspections.
• Assist in the creation and revision of applicable procedures.
• Perform other duties as assigned, including high-level responsibilities and day-to-day activities.
• Stay informed of relevant regulations and standards and ensure compliance with applicable requirements.

The above job description documents the general nature and level of work but is not intended to be an exhaustive list of activities, duties, and responsibilities required of job incumbents. Therefore, job incumbents are expected to perform all other duties as assigned or required, as training and experience allow.  

No matter your role at BridgeBio, successful team members are:

• Patient Champions, who put patients first and uphold strict ethical standards
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality executors, who execute against goals and milestones with quality, precision, and speed

Where You’ll Work 

• This a Netherlands-based remote role that will require quarterly, or as needed visits to our Amsterdam and/or Zug Office.

Who You Are

Minimum Education requirement:

• Bachelor’s degree or equivalent in science, mathematics, or engineering

Relevant Experience:

• A minimum of 8 years of experience working in a Biotech or Pharmaceutical FDA-regulated industry in QA or a related field, or an equivalent combination of education, training, and/or experience from which comparable knowledge, skills, and abilities have been attained
• Working knowledge of cGMPs (CFR/ICH/EMA) and applicable international regulations/ guidance
• Experience reviewing audit reports, quality agreements, and procedures
• Prior experience with a commercial product
• Prior experience in supporting PAI and regulatory inspection readiness
• Prefer experience in oversight of external vendors

Skills:

• Comfortable working in a virtual bio-pharmaceutical organization with multiple global third-party providers
• Strong planning and time management skills with the ability to prioritize workload
• Excellent analytical and problem-solving skills, with keen attention to detail
• Proficiency in document and presentation office tools (Microsoft Office, Google Docs, etc.)
• Basic understanding of data concepts and enterprise resource planning (ERP) systems
• Ready to embrace companies’ core values and diverse corporate culture
• Travel - 15% of time
• Eligible to work in The Netherlands

What We Offer

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
• Access to learning and development resources to help you get in the best professional shape of your life
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
• Commitment to Diversity, Equity & Inclusion