Customer Quality Operations Lead

divh2Customer Quality Operations Lead / h2pBuild your future at Curia, where our work has the power to save lives. / ppThe Customer Quality Lead will oversee and ensure the quality of API product at Curia Springfield and contracted manufacturing. The role is part of the site quality leadership team responsible for driving regulatory compliance and improving customer quality service levels. This role will manage all aspects of the Quality oversight of API, Intermediates and other GMP production from production to ensuring compliance with regulatory requirements and internal standards. / ppCuria is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers therapies from curiosity to cure and ultimately to improve patients lives. / ppWe proudly offer : / pulliGenerous benefit options (eligible first day of employment) / liliPaid training, vacation and holidays (vacation accrual begins on first day of employment) / liliCareer advancement opportunities / liliEducation reimbursement / lili401K program with matching contributions / liliLearning platform / liliAnd more! / li / ulpResponsibilities : / pulliThe Customer Quality Lead will be part of the site quality leadership team in driving regulatory compliance and improving customer quality service levels. This role will manage all aspects of the Quality oversight of API, intermediates and other GMP product from production to ensuring compliance to regulatory requirements and internal standards. / liliThis role will manage quality aspects of product lifecycle activities including deviations, change controls and complaints. This role also includes a review of product batch records, coordinate with the customer / production to address comments and disposition product lots in a timely manner to meet the business needs. / liliThis role also requires shopfloor walkthroughs to drive continuous improvements in driving site Quality culture / liliProvides on the floor feedback to operators and operational team from the review of batch records and deviations to establish and implement process improvements to enhance compliance culture / liliRepresent quality in cross-functional forums, providing oversight and support to production activities as well as to ensure quality alignment. / liliIdentify and escalate significant quality risks to senior management. Drive and support significant changes and issues management (Deviations / CAPA). / liliEnable the site Quality Head in ensuring on-time completion of customer commitments and regulatory inspection commitments. / liliResponsible to drive improvement actions for supplier audit findings and supplier complaint CAPAs. / liliParticipate in timely completion of the annual product reviews and assessment of the continued process verification and validation activities. / liliSingle point contact of accountability and primary contact for supplier product. / liliBuilds strong relationship and interact with the site quality units (QC, QA, Regulatory Affairs, etc..) to gather and assess data for responses to customers. / liliMonitors progress of agreed-upon tasks and escalate issues / delays when they arise preparing contingency plans with internal external partners. / liliReview and approve the complaint and deviation investigations, RCA and CAPAs to prevent recurrence and review the effectiveness of the implemented CAPAs. / liliResponsible for Key Account Management Metrics with KAM customers. / liliLeads initiatives to improve and harmonize quality processes driven to the improvement of customer satisfaction. / liliUnderstands and anticipates customer needs and supports the organization and main stake holders in the design of experiments for new products. / liliBuilds and maintains sufficient knowledge of site pipeline to understand the customer requests. / liliParticipate in customer meetings as required and participate in the develop master batch records according to the development phase of the product. / liliResponsible to ensure supplier QAAs are reviewed and approved by the Curia and supplier stakeholders in a timely manner. Maintains all QAA in current effective status. / liliParticipate in customer audits as needed. / liliResponsible for driving the established Corporate Quality Metrics for the site. / liliParticipate in the site Quality Management Review data analytics and improvement plan execution / liliLead the preparation of CAPAs, and monitor their completion providing updates to customers and management. / liliInteract with the Curia Quality network to share information related to quality expectations, inspections, audits, facilitating harmonization of the quality system within Curia. / li / ulpQualifications : / pulliBachelors degree in Chemistry or a related field / liliMinimum 10 -15 years QA, API process development, technical services, or Compliance experience in the pharmaceutical industry at USFDA regulated facilities / liliRequired working experience with global customers and global cross-functional teams / liliBroad knowledge of cGMP, FDA, and international regulations (e.g., 21 CFR 11, 210, 211, 820, EU GMP, ICH Q7), Quality Systems for active pharmaceutical ingredients (APIs), and familiarity with guidelines (e.g., FDA, ICH). / liliKnowledge of pharmaceutical production processes. / liliUSFDA inspection experiences (participating or leading) / liliExcellent communication and organizational skills, as well as negotiation, influencing, and collaboration skills, and demonstrated ability to work cross-functionally across internal stakeholders. / liliAbility to lead and manage projects / teams of significant scope and complexity. / liliProficient in building consensus, negotiating, and escalating issues / liliGood understanding of the importance and use of quality metrics / li / ulpOther Qualifications : / pulliMust pass a background check / liliMust pass a drug screen / liliMay be required to pass Occupational Health Screening / li / ulpEducation, experience, location and tenure may be considered along with internal equity when job offers are extended. / ppAll interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer. / p / div