QA Manager (Operations)

SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5,000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States.

Job Overview

The Manager of Quality Assurance will be responsible for quality operations in the manufacturing areas and working in collaboration with Process Development (MS/AS) and operations, to monitor and control the manufacturing environment, product testing, plant hygiene, equipment, and process validation, people and process flow patterns, training, investigations, and monitoring compliance with all requirements of good manufacturing practices.

Follow up on total quality activity to ensure that the organization’s quality operations comply with all relevant standards, regulations, licenses, and certifications. Products and services conform to specifications and meet internal and external quality expectations.

Actively provides guidance to multiple teams regarding compliance with all applicable SHL Corporate Quality and Regulatory procedures, including applicable Agency policies and regulations. The manager is directly involved in the establishment of corporate procedures. Ensures that products and/or materials are tested/released strictly under cGMP conditions and disposition is taken on time as per the committed Production Plan of every month and/or procedural requirements.

This Managerial position must have a strong knowledge and application of the CFRs and cGMPs (familiarity with multiple regulatory jurisdictions both domestically and internationally).

Main Responsibilities

• Provide management and guidance to Quality Assurance (Operations) team staff to ensure compliance with current Good Manufacturing Practices (cGMP) and company policies.
• Provide support to the Quality Control department to ensure compliance with current Good Laboratory Practices (GLP) and company policies.
• Provide oversight of the site validation program which includes Facilities, Utilities, Manufacturing Processes, Equipment, and Computer Systems.
• To ensure that the production records and testing results are complete, accurate, and documented according to established written procedures.
• To ensure that products are sampled and stored per procedure
• Coordinate with all other department management and resolve quality-related issues to ensure deviations from established procedures are documented and resolved per established procedures.
• Drive performance and accountability of the QA Ops team using meaningful metrics, performance evaluations, and development plans.
• Assist with preparation for and host Customer, Vendor, FDA, and other regulatory compliance audits.
• Direct and lead the audit function and take appropriate action to assure regulatory compliance.
• Responsible for Quality decision-making on the manufacturing floor
• SOPs/Document Management: Approve all instruction sets, specifications, sampling instructions, test methods, etc., and other Quality control procedures directly related to operations and other cGMP activities
• Deviation/CAPA Management approval: Ensure all deviations from established procedures are appropriately documented and investigated to determine and address the root cause.
• Training: Ensure all personnel, including contractors, consultants, and temporary employees have the proper qualifications, skill sets, education, and training to perform their jobs in accordance with applicable procedures and regulations
• Advises site management regarding Quality Assurance issues.
• Develop and deliver a robust overall quality system, strategy, and ultimate plan resulting in a fully compliant facility with respect to procedures and processes.
• Create monthly Quality Management Review meetings (QMR) to review plant metrics, ensure a state of control, and drive action where appropriate along with reporting on a specific set of quality and compliance metrics.
• Provide strategic quality input on the translation of commercial product requirements into a technical product profile that includes defining critical quality attributes (CQAs) and critical processing parameters (CPPs).
• Support cost improvement planning initiatives for the QA Operations team to increase productivity and efficiency of the quality unit whilst maintaining compliance.
  
  

Skills And Qualifications

• Bachelor’s or Master’s degree in chemistry, engineering, or related scientific discipline and a minimum of three (3) years of managerial experience in the same or closely related GMP environment.
• A minimum of ten (10) years of experience in pharmaceutical-based GMP manufacturing operations, including direct experience in pharmaceutical/medical device manufacturing operations.
• Demonstrated ability to effectively supervise and direct personnel and to plan and direct medium to large projects.
• Strong knowledge of applicable regulatory standards and systems: Medical Devices: ISO 13485, FDA 21 CFR Part 820 (QSR), EU MDR. Pharma: GMP, ICH guidelines, FDA 21 CFR Part 210/211.
• Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product-related investigations and deviations.
• Experience leading audits/inspections (e.g., FDA, Notified Bodies, customer audits), identifying findings, driving resolution, and providing a closure report.
• Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward
• Demonstrated ability to perform long-term project planning, team building, budgeting, and operational excellence
• Strong computer operation skills including word processing, presentation, database, and spreadsheet application skills.
• Proficient skills in solving complex problems and the ability to bring issues to resolution.
• Proficient in handling multiple responsibilities, tasks, and projects simultaneously, including ability to shift priorities.
• Demonstrate proficient ability to evaluate and apply compliance requirements/guidelines to complex situations.
• Skilled of Good Manufacturing Practices and Good Documentation practices
• Proficient skills in leading, motivating, influencing, and negotiating
  
  

We Offer

• Competitive compensation package
• Modern working environment with state-of-the-art facilities and technologies
• Challenging assignments in a fast-growing and innovative industry
• Position in a dynamic, international team of highly skilled professionals
• Various opportunities for personal and professional development within a global organization