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 harmonization of the quality system within Curia. Supervisory Responsibilities: This position is an individual contributor role. May assist QA leadership in mentoring and coaching QA Specialists, as requested. Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Other Qualifications + Must pass a background check + Must pass a drug screen + May be required to pass Occupational Health Screening Education: + Minimum Bachelor of Science degree in Biology or a related scientific field. Experience: + Minimum 10-15 years in QA, API process development, technical services, or GMP Compliance experience in the pharmaceutical industry at USFDA regulated facilities. + Required working experience with managing global customers and global cross-functional teams + Broad knowledge of cGMP, FDA, and international regulations (e.g., 21 CFR 11,