Quality Assurance Manager, Manufacturing Quality Operations

Bora Pharmaceuticals; Maple Grove (MN); In loco; USD 120.000 - 160.000; Tempo pieno

Descrizione del lavoro

Bora Pharmaceuticals, a premier CDMO, seeks a senior QA leader to oversee commercial manufacturing quality, CAPA, batch review, and training programs. You will drive GMP compliance, partner across Operations, Quality Control, and Engineering, and mentor a team of QA specialists and training professionals.

Engineering a robust quality system, you will own training governance, metrics, and inspection readiness, ensuring seamless transition of products from project mode to steady-state operations

Competenze

• Bachelor's degree in life sciences (chemistry, biology) or engineering.
• Minimum of 8 years of Quality Assurance experience in pharmaceutical or medical device industries.
• Minimum of 2 years of leadership or supervisory experience.
• Broad knowledge of manufacturing/packaging QA, batch-record review, deviation/CAPA, complaint investigations, product disposition, GMP training systems.

Mansioni

• Provides direct supervision, performance management, coaching, resource planning, scheduling, workload prioritization, and professional development for QA staff.
• Provides daily QA support and shop-floor/operational QA coverage for commercial manufacturing and packaging activities.
• Oversees review and approval of batch records, logbooks, procedures, and GMP documents.
• Manages deviation records, investigations, root-cause analysis, and CAPA execution.
• Reviews CAPAs, ensures follow-up with evidence and action.
• Owns final product disposition for routine commercial products after validation of quality records.
• Supports audits by presenting QA processes, training controls, and records.
• Drives continuous improvement in QA coverage, batch review, investigations, and training processes.

Conoscenze

Leadership

Quality assurance leadership

Regulatory compliance

Cross-functional collaboration

Verbal & written communication

Problem solving

Formazione

Bachelor's degree in life sciences or engineering

Strumenti

TrackWise

Veeva Vault

Descrizione del lavoro

Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora's teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer's success more certain.

Job Summary:

Leads routine Quality Assurance oversight of commercial pharmaceutical manufacturing and packaging operations. Provides day-to-day GMP support across shop-floor operations, batch-record review, investigations, CAPA execution, complaint support, product disposition, and production escalations. Provides leadership and technical direction to Product Quality Specialists, Quality Associates, and the site Training team. Owns the site GMP training system, including curriculum governance, assignment and completion controls, learning management system administration, qualification programs, training effectiveness, metrics, and inspection support. Ensures continued Quality support after products transition from project mode into steady-state commercial operations and partners across Operations, Technical Services, Quality Control, Engineering, Client & Project Quality, Quality Systems, and functional management. Develops and trends operational, QMS, compliance, supplier-quality, computerized system validation, and training metrics to support management review and continuous improvement.

Essential Functions:

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Provides direct supervision, performance management, coaching, resource planning, scheduling, workload prioritization, and professional development for Product Quality Specialists, Quality Associates, and the Training team.
• Provides daily QA support and shop-floor or operational Quality coverage for commercial manufacturing and packaging activities.
• Oversees review and approval of executed batch records and routine master batch records, logbooks, procedures, and other GMP documentation supporting commercial operations.
• Manages manufacturing and packaging deviation records, investigation support, root-cause evaluation, approval, and timely completion in accordance with the Quality Systems process.
• Reviews operational CAPAs, monitors follow-up, and verifies that actions are implemented and supported by appropriate evidence.
• Assesses manufacturing and packaging changes for product, process, validation, documentation, and compliance impact and executes change records within the governed change-control process.
• Owns final product disposition for routine commercial products after confirming completion and compliance of applicable batch documentation and quality records.
• Manages routine complaint investigation support, including coordination of operational evidence, root-cause analysis, corrective actions, and documentation; Client & Project Quality supports significant client communications and relationship escalations.
• Manages production-related Quality escalations and provides timely, risk-based Quality decisions and resource coordination.
• Owns the site GMP training system and directly oversees the Training team, including needs assessment, curriculum governance, training assignment and completion controls, LMS administration, training effectiveness, qualification programs, metrics, and inspection support.
• Partners with functional managers, who remain accountable for ensuring their personnel complete required training and apply training in job performance.
• Develops, reviews, trends, and reports QMS, compliance, supplier-quality, CSV, and training metrics for management review and continuous improvement.
• Develops, reviews, and reports operational quality metrics, workload indicators, deviation performance, batch-review status, complaint performance, and disposition status.
• Accepts products into routine commercial Quality support after documented transfer-to-operations readiness criteria are met and maintains ongoing product quality support thereafter.
• Collaborates with Operations, Technical Services, Quality Control, Engineering, Client & Project Quality, and Quality Systems to resolve operational issues and maintain compliance.
• Supports customer and regulatory audits by presenting manufacturing Quality processes, training-system controls, and records; Client & Project Quality coordinates customer-audit hosting and Quality Systems manages inspection infrastructure and system-level responses.
• Drives continuous improvement in operational QA coverage, batch review, investigations, disposition, complaint support, production escalation, and site GMP training processes.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

Minimum Education, Experience, and Skills

• Bachelor's degree (BA/BS) in life sciences, such as chemistry, biology, or a related discipline, or in engineering.
• Minimum of 8 years of Quality Assurance experience in the pharmaceutical or medical device industry.
• Minimum of 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.

Preferred: 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.