Principal Functional Lead, Quality Programs

Job Overview

This role is responsible for leading quality‑related initiatives, i.e. MQRB, CAPA and Regulatory Audits, including identifying quality deliverables as outlined in the Quality Processes. The position plays an important role in enabling regulatory readiness and serves as the Backroom Manager during audits and inspections.  You are responsible for leading and directing the workload of Quality System (QS) projects as required with key quality deliverables as specified. This role is responsible for managing the timelines for QS initiatives including CAPAs, audit programs, responses, QMS compliance efforts, and system-level improvements to ensure adherence to FDA and global regulatory standards. This role is to manage the QMS elements, while supporting the implementation and deployment of Quality Process enhancements. In this role, you will use your experience or expertise to develop and deliver on quality requirements, solve problems, influence a quality minded culture, develop and execute objectives for self and others, and be able to effect short-term and long-term /business goals. Contribute to continuous improvement initiatives to enhance quality project delivery and operational effectiveness.

Job Responsibilities and Essential Duties

• Work with Quality System team to develop and maintain timelines and milestones for assigned Quality initiatives by leading and managing the following Quality elements:
• Corrective and Preventive Actions (CAPAs) process – tracking approved CAPAs, and driving timely/appropriate completion of activities, ensuring root cause analysis, actions, verification of effectiveness as appropriate.
• CAPA Review Board (CRB) governance
• Management System Plans (MSPs) – Issuance, review, monitoring of actions and tracking status to closure.
• External Audit Program and the coordination of responses.
• Work with QS team to define scope, deliverables, timelines, and milestones for QMS elements to completion.
• Develop and maintain QMS updates and progress to completion
• Work with Program Management to align resources impacting quality projects.
• Ensure alignment of projects within the QMS requirements and regulatory agency expectations
• Drive continuous improvement of Quality Systems processes and tools
• Partner with site Quality, Regulatory, Program Management, Engineering, Manufacturing, and Operations teams, as well as appropriate Global functions.

Audit Management

• Serve as Backroom Manager for External audits (FDA, Notified Bodies, Customers, etc.)
• Coordinate audit logistics, training, documentation readiness, and subject matter expert (SME) support
• Lead post-audit activities including observations, CAPAs, and commitments tracking

Governance & Reporting

• Generate status updates.
• Work with PMO regarding overall Quality System updates for project reviews.
• Ensure effective escalation and resolution of quality project risks and delays

Project Risk Management & Compliance

• Identify and proactively manage risks related to compliance and quality system performance
• Ensure QS elements meet regulatory requirements (FDA, ISO 13485, GMP, etc.)
• Maintain alignment with Global processes and initiatives

Minimum Requirements

• Minimum of a bachelor’s degree in engineering or science, or equivalent experience
• Minimum of seven years of experience in medical device, pharmaceutical, or regulated industry.
• Good ability to drive continuous improvement, correct deficiencies and to prevent recurrence
• Strong knowledge of Quality Management Systems (QMS), FDA regulations (21 CFR Part 820 / 21 CFR Part 11), and ISO 13485 and applicable global standards

Required Knowledge, Skills and Abilities

• Demonstrated experience managing Quality Systems elements (CAPA, audits, regulatory inspections, and compliance initiatives)
• Strong understanding of audit processes and regulatory inspections
• Proven ability to drive complex projects and continuous improvement, correct deficiencies and to prevent recurrence to closure
• Excellent attention to detail, communication, problem-solving, analytical, and organizational skills.
• Ability to manage multiple priorities in a fast-paced environment
• Proficient computer skills required; expert knowledge of Microsoft Office (including Word, PowerPoint and Excel) required, experience with Enterprise Resource Planning (ERP) system (such as SAP) required.

Preferred Qualifications

• Certified Quality Auditor (CQA), Six Sigma, or similar certification
• Experience serving as an audit backroom lead

Supervision/Management Of Others:

• This position does not have direct supervisory responsibility.

Internal and External Contacts/Relationships

• All levels internally and externally.