This is an onsite position requiring the team member to be onsite 5 days a week.No relocation is provided for this opportunity.Job SummaryThe primary responsibilities of the Senior Quality Systems Specialist involve Systems oversight & customer focus within our all-Quality Management Systems, relaying trends to Senior Management and implementing improvements on a continuous and pro-active basis. You will coordinate necessary activities for ensuring the timely closure of internal/external quality issues/projects and to coordinate/drive continuous improvement initiatives including mentoring to the business with respect to the relevant quality tools. Central to this role will be the need to liaise with companywide departments to ensure internal system compliance and customer specifications are achieved and to coach and drive a culture of compliance and continuous improvement. Ensuring site compliance with corporate, regulatory and customer quality standards will be at the forefront of the responsibilities. This role reports directly to the Quality Systems Manager.
Essential Duties and Responsibilities- Support the harmonization and deployment of site quality systems into standardized Operating Unit-level processes, ensuring effective implementation, consistency, and the sharing of best practices across the network.
- Provide training and guidance on Quality Management System (QMS) processes, including Change Management, CAPA, Deviation Management, Document Control, and associated compliance requirements.
- Manage key quality system processes at site level, including Global Alerts, Document Control System sub-administration, CAPA governance, and Change Management oversight.
- Lead and support investigations related to Quality System issues, ensuring robust root cause analysis and the implementation of effective containment, corrective, and preventive actions.
- Identify, monitor, trend, and escalate systemic quality risks, adverse trends, significant quality events, and compliance concerns to appropriate stakeholders and senior leadership.
- Monitor quality system performance through metrics, trend analysis, and key reports, and recommend actions to improve compliance, effectiveness, and overall system performance.
- Support regulatory submissions, responses to Regulatory Bodies and Competent Authorities, and inspection readiness activities for internal audits, external audits, Notified Bodies, FDA, and other regulatory authorities.
- Support risk management activities, including risk analysis and hazard analysis associated with complaints, post-market surveillance information, and other quality system inputs, as applicable.
- Coordinate post-audit and post-inspection follow-up activities, including action tracking, reporting, closure, and verification of effectiveness to ensure findings are satisfactorily addressed.
- Support Management Review activities through scheduling, data collection, reporting, and presentation of key quality system information and performance trends.
- Participate in the review, development, implementation, and continuous improvement of procedures, processes, and systems in line with regulatory requirements and industry best practices.
- Partner with cross-functional teams and site leadership to embed quality system compliance, promote data integrity, and foster a culture of compliance, accountability, and continuous improvement.
- Perform additional duties as assigned by the direct supervisor.
Education- Bachelor's Degree in Engineering, Quality, Science or equivalent experience required
Work Experience- Minimum of 5 years' experience of working in a high-volume manufacturing environment ideally in the pharmaceutical industry.
- Working knowledge of quality systems such as ISO 13485 / 21 CFR Part 820 QMSR/21 CFR Part 210/211 is essential.
Preferred Knowledge, Skills and Abilities- Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
- Able to comply with the company's safety policy at all times.
- Able to comply with the company's quality policy at all times.
- Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 QMSR, 21 CFR Part 4, 21 CFR Part 210/211, EU GMP Volume 4 is preferred.
- A background in drug handling would be considered an advantage.
Additional Requirements- Thrive in a fast-paced environment where teamwork and collaboration drive success.
- Bring a positive, can-do attitude every day as we build and grow together.
- Contribute to ramping up a state-of-the-art manufacturing facility from the ground up.
- Embrace change and innovation as we launch new operations at record speed.
- Work hard, stay flexible, and support your teammates to achieve shared goals.
- Take pride in producing high-quality products that improve patient lives worldwide.
- Live West's core values of integrity, teamwork, and accountability in everything you do.
- Be part of a culture that celebrates learning, problem-solving, and continuous improvement.
- Show initiative and ownership while helping shape a safe, efficient, and high-performing workplace.
- Grow your career and skillset in a dynamic, innovative environment where your contributions truly matter. #LI-JJ1 #LI-ONSITE
Travel Requirements5%: Up to 13 business days per year
Physical RequirementsSedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
