Customer Quality Lead (QA)

Quality Assurance (QA) Customer Quality Lead 

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

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! 

Essential Duties and Responsibilities include the following:

• Reports to the site Quality Head and is responsible for demonstrating exemplary customer quality service to internal and external customers.

• Writes and reviews customer product investigations. This role also coordinates with Quality Assurance (QA) to address customer comments related to batch records and ensures disposition of product lots in a timely manner to meet the customer needs. 

• Coordinates and/or prepares temporary or planned change controls associated with customer product(s) as needed. 

• Enables the site Quality Head by ensuring on-time completion of customer commitments and regulatory commitments, specific to customer projects.

• Responsible to ensure timely completion of the annual product reviews and assessment of the continued process verification and validation activities.

• Represents the primary point of contact for customer-related queries from the Sales and Business Development teams.

• Builds strong relationships with key stakeholders (QC, QA, Regulatory Affairs, etc.) to obtain and assess data to fulfill customer requests or inquiries.  

• Coordinates and assists with customer requests, including those to support customer filings and/or amendments. Liaise with Regulatory Affairs and the site stakeholders to ensure review(s) of filings and/or amendments are met per QAA requirements.

• Monitors progress of agreed-upon tasks and escalates issues/delays to the site Quality Head when they arise, preparing contingency plans with internal partners.

• Reviews and approves customer complaint investigations and assesses root cause analysis.  Implements CAPAs and reviews the effectiveness of the implemented CAPAs. 

• 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 stakeholders in the new product introduction process for QC and QA activities. 

• Builds and maintains sufficient knowledge of site pipeline to understand customer requests.

• Participates in customer meetings as required and supports the development phase of the product as needed.

• Responsible for ensuring all QAAs are reviewed and approved by Curia, the customer stakeholders in a timely manner. Maintains all QAAs to ensure the most current effective version is accessible.  

• Coordinates with site Compliance team to schedule customer audits and assist with audits as needed. 

• Leads and drives GMP activities associated with customer products and work with Managers and Supervisors to complete associated deviation investigations on time.

• Participates in the site Quality Management Review, provide data as needed and improvement plan execution.

• Oversees customer specific CAPAs. Monitors CAPA completion and provide updates to customers and management.

• Interacts with the Curia Quality network to share information related to quality expectations, inspections, audits, and facilitating harmonizati