Manager/Sr. Manager, Quality Assurance Operations

Mavericks WantedWhen 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 onIn 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 DoThe 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. ResponsibilitiesMajor Responsibilities / Accountabilities:Manage batch release activities and communication of batch release schedules to key stakeholdersReview 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 protocolsPerform quality review and guide quality events (deviations, OOSs/OOTs, change requests, supplier notifications, etc.) as documented by contract manufacturers and manufacturing operations departmentsCommunicate manufacturing deficiencies/non-conformances to management and work with vendors to ensure timely resolutionRepresent QA on project teams responsible for drug substance and drug product manufacturing and testingOther Quality Assurance Operations-related responsibilities:Participate in the GMP vendor qualification, vendor audit, partner audit, and regulatory inspections as neededMonitor CMO performanceReview process and method validation protocols and reportsReview analytical test results to ensure compliance with approved specificationsParticipates as QA person-in-plant, internal, and external meetingsWrite and review SOPs and quality assurance proceduresOther duties as assignedWhere You'll WorkThis is a Netherlands.-based remote role that will require as needed visits.Who You AreBachelor’s degree or equivalent in science, mathematics, or engineeringA 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 attainedPreferably a QP or working experience with QP for batch release activitiesWorking knowledge of cGMPs (CFR/ICH/EMA) and applicable international regulations/ guidancePrior experience with a commercial productPrior quality control/analytical development experiencePrefer experience in oversight of external vendorsComfortable working in a virtual bio-pharmaceutical organization with multiple global third-party providersExcellent analytical, critical-thinking, and problem-solving skills, with keen attention to detailAbility to engage in cross-functional interactions with internal and external staffStrong planning and time management skills with the ability to prioritize workloadProficiency in document and presentation office tools (Microsoft Office, Excel, etc.)Basic understanding of data concepts and enterprise resource planning (ERP) systemsReady to embrace companies’ core values and diverse corporate cultureTravel - 15% of time, domestic or internationalEligible to work in The Netherlands Rewarding Those Who Make the Mission PossibleWe have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. Financial, Health & Wellbeing Benefits:Market leading compensation Referral program with $2,500 award for hired referralsHybrid work model - employees have the autonomy in where and how they do their work 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 mobilityWe provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp CoachingWe celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunitiesOriginally posted on Himalayas

Apply Now