Customer Quality Operations Lead

Careers|CURIA • Springfield, MO

9d

About The Position

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!

Requirements

• Bachelor’s degree in Chemistry or a related field
• Minimum 10 -15 years QA, API process development, technical services, or Compliance experience in the pharmaceutical industry at USFDA regulated facilities
• Required working experience with global customers and global cross-functional teams
• Broad 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).
• Knowledge of pharmaceutical production processes.
• USFDA inspection experiences (participating or leading)
• Excellent communication and organizational skills, as well as negotiation, influencing, and collaboration skills, and demonstrated ability to work cross-functionally across internal stakeholders.
• Ability to lead and manage projects/teams of significant scope and complexity.
• Proficient in building consensus, negotiating, and escalating issues
• Good understanding of the importance and use of quality metrics
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

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 Account Management Metrics with KAM customers.
• Leads initiatives to improve and harmonize quality processes driven to the improvement of customer satisfaction.
• Understands and anticipates customer needs and supports the organization and main stake holders in the design of experiments for new products.
• Builds and maintains sufficient knowledge of site pipeline to understand the customer requests.
• Participate in customer meetings as required and participate in the develop master batch records according to the development phase of the product.
• Responsible 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.
• Participate in customer audits as needed.
• Responsible for driving the established Corporate Quality Metrics for the site.
• Participate in the site Quality Management Review data analytics and improvement plan execution
• Lead the preparation of CAPAs, and monitor their completion providing updates to customers and management.
• Interact with the Curia Quality network to share information related to quality expectations, inspections, audits, facilitating harmonization of the quality system within Curia.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees