QA Manager, Manufacturing Quality Operations

Bora Pharmaceuticals•Maple Grove, MN

About The Position

The QA Manager leads routine Quality Assurance oversight of commercial pharmaceutical manufacturing and packaging operations. The role provides day-to-day GMP support across shop-floor operations, batch-record review, investigations, CAPA execution, complaint support, product disposition, and production escalations. It provides leadership and technical direction to Product Quality Specialists, Quality Associates, and the site Training team. The position owns the site GMP training system, including curriculum governance, training assignment and completion controls, learning management system administration, qualification programs, training effectiveness, metrics, and inspection support. It ensures continued Quality support after products transition from project mode to steady-state commercial operations and partners with Operations, Technical Services, Quality Control, Engineering, Client & Project Quality, Quality Systems, and functional management. The role develops and trends operational, QMS, compliance, supplier-quality, computerized system validation, and training metrics to support management review and continuous improvement. The manager supports customer and regulatory audits by presenting manufacturing Quality processes, training-system controls, and records. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. The listed duties are not exhaustive, and management may assign or reassign responsibilities.

Requirements

Bachelor's degree (BA/BS) in life sciences, such as chemistry or biology, a related discipline, or engineering.
At least 8 years of Quality Assurance experience in the pharmaceutical or medical device industry.
At least 2 years of leadership or supervisory experience.
Broad working knowledge of manufacturing and packaging Quality Assurance, batch-record review, deviation and CAPA execution, complaint investigations, product disposition, regulatory compliance, and GMP training systems.
Excellent verbal and written communication skills, including the ability to present complex QA and training topics to cross-functional stakeholders, senior leadership, and regulatory auditors.
Demonstrated leadership and coaching abilities, including experience managing performance and developing multidisciplinary teams.
Strong knowledge of cGMP regulations, including 21 CFR Parts 210 and 211, and FDA inspection expectations for pharmaceutical manufacturing, packaging, and training systems.
Proven ability to lead operational QA support, investigations, root-cause analysis, CAPA development, batch review, product disposition, complaint support, and production escalations.
Demonstrated experience with training needs assessment, curriculum governance, learning management system administration, qualification programs, completion controls, and training-effectiveness assessment.
Ability to develop, trend, interpret, and report QMS, compliance, supplier-quality, computerized system validation, operational, and training metrics.
Strong analytical, problem-solving, and independent decision-making skills, with high attention to detail.
Proficiency with computer applications and quality, documentation, and learning management systems, such as TrackWise, Veeva Vault, or equivalent.
Proven collaboration skills and ability to work effectively across multiple functional teams and with functional managers accountable for employee training completion and application.
Ability to manage changing priorities and multiple workstreams simultaneously in a fast-paced manufacturing environment.

Nice To Haves

Quality certification, such as ASQ Certified Quality Auditor or equivalent.
Working knowledge of EU pharmaceutical regulations and guidelines applicable to manufacturing, documentation, and quality systems.

Responsibilities

Provide direct supervision, performance management, coaching, resource planning, scheduling, workload prioritization, and professional development for Product Quality Specialists, Quality Associates, and the Training team.
Provide daily QA support and shop-floor or operational Quality coverage for commercial manufacturing and packaging activities.
Oversee review and approval of executed batch records and routine master batch records, logbooks, procedures, and other GMP documentation supporting commercial operations.
Manage manufacturing and packaging deviation records, investigation support, root-cause evaluation, approval, and timely completion in accordance with the Quality Systems process.
Review operational CAPAs, monitor follow-up, and verify implementation with appropriate supporting evidence.
Assess manufacturing and packaging changes for product, process, validation, documentation, and compliance impact, and execute change records through the governed change-control process.
Own final product disposition for routine commercial products after confirming applicable batch documentation and quality records are complete and compliant.
Manage routine complaint investigation support, including coordination of operational evidence, root-cause analysis, corrective actions, and documentation.
Manage production-related Quality escalations and provide timely, risk-based Quality decisions and resource coordination.
Own the site GMP training system and oversee needs assessment, curriculum governance, training assignment and completion controls, LMS administration, training effectiveness, qualification programs, metrics, and inspection support.
Partner with functional managers, who remain accountable for ensuring their personnel complete required training and apply it in their job performance.
Develop, review, trend, and report QMS, compliance, supplier-quality, CSV, training, and operational quality metrics for management review and continuous improvement.
Report workload indicators, deviation performance, batch-review status, complaint performance, and disposition status.
Accept products into routine commercial Quality support after documented transfer-to-operations readiness criteria are met, and maintain ongoing product quality support.
Collaborate with Operations, Technical Services, Quality Control, Engineering, Client & Project Quality, and Quality Systems to resolve operational issues and maintain compliance.
Support customer and regulatory audits by presenting manufacturing Quality processes, training-system controls, and records.
Drive continuous improvement in operational QA coverage, batch review, investigations, disposition, complaint support, production escalation, and site GMP training processes.