Senior Quality Management Systems Manager

Location: Charleston, South Carolina, US

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

Develops, establishes, and maintains the quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and regulatory agency guidelines to ensure continued customer satisfaction. Provides leadership that results in the implementation and achievement of the quality policy and functional objectives including initiatives in conjunction with the Associate Director of Quality.

Main Responsibilities

• Implement and maintain Charleston site Quality Management System in accordance with ISO 13485 and FDA regulations.
• Establish and maintain training system. Provide training, as appropriate.
• Coordinate, compilate and present Site Management Review. Responsible for trending/analysis of key performance indicator (KPI) data based on SOPs for recording, evaluation and reporting of Quality and reliability data.
• Plan, coordinate, and conduct scheduled internal audits to assess compliance with FDA, ISO, other applicable standard requirements, and internal requirements.
• Maintain and monitor Change Control process. Own and process change control records, as appropriate.
• Represent Charleston site in global conferences and meetings related to the site quality management system.
• Responsible for the implementation, co-ordination, and review of the CAPA system. Facilitates CAPA management in other areas of the organization.
• Leads and coordinates efforts regarding external audit preparation, execution, and closure activities for each audit. Interfaces directly with Quality Management System Process and Sub-Process owners, Subject Matter Experts, and Management and Global Quality Systems personnel, as needed, to ensure functions are clear regarding scope of each audit and expectations of readiness to support all audits involving those functions. Responsibilities include logistical preparation such as developing audit support staffing plans, communicating status of audit preparation, and leading preparation meetings with SMEs.
• Front and/or backroom audit support.
• Oversee Material Review Board (MRB) and the investigation process.
• Coordiante root cause analysis training.
• Oversee batch release process and coordinate product release.
• Maintain supplier qualifications and overall maintenance of supplier quality process.
• Work with Quality and other leaders to identify areas within the quality management system in need of improvement and manage Corrective and Preventive Actions, as appropriate.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities.
• Perform additional tasks as needed for the support Production systems (MES, SAP).
• Lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports.

Skills and Qualification

• Bachelor’s degree in Life Science or equivalent.
• Minimum of 8+ years’ experience in Quality Management Systems or medical device field.
• Demonstrated leadership and people management experience within a functional management role.
• Comprehensive understanding of the QSR, cGMP and ISO/MDD standards.
• Excellent communication skills with the ability to influence others.
• High level of initiative & autonomy through continuous questioning of current practices.
• Fluent in English.
• Effective team member, motivated to achieve and demonstrate best practices in line with the department and global objectives.

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

Please note that SHL is a drug free employer. This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check.

For more information on SHL Medical, please visit: shl-medical.com