Customer Quality Lead (QA)

Curia • Rensselaer, NY

16h

About The Position

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. The Customer Quality Lead (QA) is responsible for demonstrating exemplary customer quality service to internal and external customers. This role writes and reviews customer product investigations, coordinates with Quality Assurance (QA) to address customer comments related to batch records, and ensures timely disposition of product lots to meet customer needs. The lead also coordinates and/or prepares temporary or planned change controls associated with customer products, enables the site Quality Head by ensuring on-time completion of customer and regulatory commitments specific to customer projects, and is responsible for the timely completion of annual product reviews and assessment of continued process verification and validation activities. This position represents the primary point of contact for customer-related queries from Sales and Business Development teams, builds strong relationships with key stakeholders (QC, QA, Regulatory Affairs, etc.) to obtain and assess data for customer requests or inquiries, and coordinates and assists with customer requests, including those to support customer filings and/or amendments. The role liaises with Regulatory Affairs and 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 with contingency plans. Additionally, the lead reviews and approves customer complaint investigations, assesses root cause analysis, implements CAPAs, and reviews their effectiveness. They lead initiatives to improve and harmonize quality processes to enhance customer satisfaction, understand and anticipate customer needs, and support new product introduction for QC and QA activities. The lead maintains knowledge of the site pipeline to understand customer requests, participates in customer meetings, and supports product development phases. They are responsible for ensuring all QAAs are reviewed and approved by Curia and customer stakeholders in a timely manner and maintains all QAAs for accessibility. The lead coordinates with the site Compliance team for customer audits and assists as needed, leads GMP activities for customer products, and works with Managers and Supervisors to complete associated deviation investigations. They participate in the site Quality Management Review, provide data, and execute improvement plans, and oversee customer-specific CAPAs, monitoring their completion and providing updates. The role interacts with the Curia Quality network to share information on quality expectations, inspections, audits, and facilitates quality system harmonization. This position is an individual contributor role but may assist QA leadership in mentoring and coaching QA Specialists.

Requirements

• Minimum Bachelor of Science degree in Biology or a related scientific field.
• 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, 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 manufacturing operations.
• USFDA inspection experience (e.g., participant or has interacted with Investigators).
• Excellent communication and organizational skills, as well as negotiation, influencing, and collaboration skills, and demonstrated ability to work cross-functionally across internal stakeholders.
• Proficient in building consensus, negotiating, and escalating issues; and proven customer service.
• 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

• 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.
• 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.
• May assist QA leadership in mentoring and coaching QA Specialists, as requested.

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
• And more!

What This Job Offers

• Job Type: Full-time
• Career Level: Senior