Customer Quality Lead (QA)

About the role

Reports to the site Quality Head and is responsible for demonstrating exemplary customer quality service to internal and external customers. This role 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 customer needs. Represents the primary point of contact for customer-related queries from the Sales and Business Development teams.

Responsibilities

• Writes and reviews customer product investigations
• 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
• Ensures timely completion of annual product reviews and assessment of continued process verification and validation activities
• 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
• 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 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 implemented CAPAs
• Leads initiatives to improve and harmonize quality processes driven to 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
• Ensures all QAAs are reviewed and approved by Curia and 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 works with Managers and Supervisors to complete associated deviation investigations on time
• Participates in site Quality Management Review, provides data as needed and improvement plan execution
• Oversees customer specific CAPAs
• Monitors CAPA completion and provides 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.

• 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, 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)

Skills

• Excellent communication and organizational skills
• Negotiation, influencing, and collaboration skills
• Demonstrated ability to work cross-functionally across internal stakeholders
• Proficient in building consensus, negotiating, and escalating issues
• Proven customer service
• Good understanding of the importance and use of quality metrics

Pay

$117,000 - $146,500. Education, experience, location and tenure may be considered along with internal equity when job offers are extended.