Sr. Manager, QA Operations - Product Release

Mavericks Wanted

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

Manage lot release activities at the company’s Contract Manufacturing  Organizations (CMOs). The individual will act as QA Operations lead with assigned CMOs, including  review of manufacturing batch records, certificates of analysis and the issuance of certificates of compliance. The Sr. Manager, QA Operations - Product Release will ensure that the CMO SOPs and Master Batch Records are in compliance with cGMPs and will serve as the technical quality reviewer for deviations, change records, protocols, and CAPAs generated from or pertaining to Calcilytix or other BridgeBio affiliates, as needed. 

Responsibilities

• Represent QA Operations on internal and external project teams, audits and inspections, and participate in monitoring of CMO performance.
• Review and manage master and executed manufacturing batch records from CMOs, including release activities, and  related documents such as specifications, analytical and microbiological methods, stability study/protocols, process and method validation protocols and reports.
• Author and perform quality review of SOPs and quality events (deviations/investigations, OOSs/OOTs, change controls, supplier notifications, etc.).
• Lead disposition of Drug Substance (DS), Drug Product (DP) and Finished Product (FP).
• Communicate/escalate manufacturing deficiencies/non-conformances to management, present issues during escalation, and work with CMOs to ensure timely resolution
• Support review of regulatory filings
• Support audit of CMOs

Where You'll Work

This is a hybrid role and requires in-office collaboration 2-3x per week in our San Francisco Office or a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.

Who You Are

• Bachelor's Degree in a science discipline with 8+ years of experience within a biopharmaceutical company, or contract research organization
• Strong knowledge of GMP, SOPs, Quality Systems (e.g. Lot Release, Deviation, Change Control, CAPA), ICH and GxP principles
• General knowledge of FDA and other global clinical trial regulations
• Prior experience in QC, Analytical Development and process validation highly desired
• Excellent verbal and written communication skills, with a strong customer focus
• Excellent organizational skills, ability to manage multiple tasks and competing priorities, and maintain meticulous attention to detail
• Travel up to 10% total time

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• Market leading compensation 
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work 
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability 
• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

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