Manager/Sr. Manager, Quality Assurance Operations

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

The Manager/Senior QA Operations Manager reports directly to the Director, QA, tasked with manufactured batch release activities of drug substance (DS) and drug product (DP), providing oversight of commercial contract manufacturing organizations (CMOs), ensuring compliance with the current regulated standards and internal procedures.  The position requires strong analytical and critical thinking skills and the ability to provide review input to complex batch-related deviations/investigations/root cause analysis at the CMOs. This position at BridgeBio Affiliate (Eidos Therapeutics) will require strong cross-functional collaboration with internal stakeholders and external parties. 

Responsibilities

Major Responsibilities / Accountabilities:

• Manage batch release activities and communication of batch release schedules to key stakeholders
• Review and approve drug substance, drug product master, and manufacturing batch records and certificate of analysis from CMOs, including related documents such as specifications, analytical method transfer/method validation documents, and stability study protocols
• Perform quality review and guide quality events (deviations, OOSs/OOTs, change requests, supplier notifications, etc.) as documented by contract manufacturers and manufacturing operations departments
• Communicate manufacturing deficiencies/non-conformances to management and work with vendors to ensure timely resolution
• Represent QA on project teams responsible for drug substance and drug product manufacturing and testing

Other Quality Assurance Operations-related responsibilities:

• Participate in the GMP vendor qualification, vendor audit, partner audit, and regulatory inspections as needed
• Monitor CMO performance
• Review process and method validation protocols and reports
• Review analytical test results to ensure compliance with approved specifications
• Participates as QA person-in-plant, internal, and external meetings
• Write and review SOPs and quality assurance procedures
• Other duties as assigned

Where You'll Work

This is a Netherlands.-based remote role that will require as needed visits.

Who You Are

• Bachelor’s degree or equivalent in science, mathematics, or engineering
• 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
• Preferably a QP or working experience with QP for batch release activities
• Working knowledge of cGMPs (CFR/ICH/EMA) and applicable international regulations/ guidance
• Prior experience with a commercial product
• Prior quality control/analytical development experience
• Prefer experience in oversight of external vendors
• Comfortable working in a virtual bio-pharmaceutical organization with multiple global third-party providers
• Excellent analytical, critical-thinking, and problem-solving skills, with keen attention to detail
• Ability to engage in cross-functional interactions with internal and external staff
• Strong planning and time management skills with the ability to prioritize workload
• Proficiency in document and presentation office tools (Microsoft Office, Excel, 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, domestic or international

Eligible to work in The Netherlands 

Rewarding Those Who Make the Mission Possible

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