Customer Quality Operations Lead

Customer Quality Operations Lead in Springfield, MO

Build your future at Curia, where our work has the power to save lives.

The 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.

Curia 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.

We proudly offer

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
  And more

Responsibilities

• The 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.
• This 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.
• This role also requires shopfloor walkthroughs to drive continuous improvements in driving site Quality culture
• Provides 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
• Represent quality in cross-functional forums, providing oversight and support to production activities as well as to ensure quality alignment.
• Identify and escalate significant quality risks to senior management. Drive and support significant changes and issues management (Deviations/CAPA).
• Enable the site Quality Head in ensuring on-time completion of customer commitments and regulatory inspection commitments.
• Responsible to drive improvement actions for supplier audit findings and supplier complaint CAPAs.
• Participate in timely completion of the annual product reviews and assessment of the continued process verification and validation activities.
• Single point contact of accountability and primary contact for supplier product.
• Builds strong relationship and interact with the site quality units (QC, QA, Regulatory Affairs, etc..) to gather and assess data for responses to customers.
• Monitors progress of agreed-upon tasks and escalate issues/delays when they arise preparing contingency plans with internal & external partners.
• Review and approve the complaint and deviation investigations, RCA and CAPAs to prevent recurrence and review the effectiveness of the implemented CAPAs.
• Responsible for Key