Sr. Manager Quality Compliance

PDI•Town of Orangetown, NY

13h•$160,000 - $190,000•Onsite

About The Position

The Senior Manager, Quality & Compliance is responsible for providing strategic leadership, oversight, and continuous improvement of the site Quality Management System (QMS) to ensure ongoing compliance with applicable regulatory requirements and industry standards for pharmaceutical, medical device, cosmetic, and EPA manufacturing operations. This role serves as the site process owner for the overall Quality Management System and Quality Compliance, with responsibility for the development, implementation, maintenance, and effectiveness of core quality system processes, including Internal and Third Party Audits, Supplier Quality, Management Review, Regulatory Inspection Readiness, Data Integrity, and Quality Metrics. The Senior Manager Quality & Compliance partners with cross-functional stakeholders to foster a culture of quality, compliance, operational excellence, and continuous improvement while ensuring adherence to FDA, Health Canada, ISO 13485, EU GMP, ICH, and other applicable regulations and standards. The position is accountable for maintaining a state of inspection readiness and driving sustainable compliance strategies that support business growth, product quality, patient safety, and customer satisfaction.

Requirements

Bachelor’s degree in a scientific discipline is required, or equivalent related experience.
Extensive knowledge of pharmaceutical, medical device, and/or cosmetic Quality Management Systems.
Expert knowledge of FDA regulations, 21 CFR Parts 210, 211, 820, ISO, Health Canada, ICH guidelines, GDP, and Data Integrity requirements.
Extensive understanding of Quality Risk Management, regulatory inspection management, audit practices, and compliance frameworks.
Knowledge of Lean, Six Sigma, and continuous improvement methodologies.
10+ years of progressive Quality Assurance, Quality Systems, and Compliance experience within a life sciences technology driven organization.
10+ years of leadership experience managing Quality Systems, Compliance, or Quality Assurance teams.
Experienced ownership of site-wide Quality Management Systems.
Proven experience leading regulatory inspections and managing interactions with FDA, Health Canada, and other regulatory agencies.
Significant experience managing audits, CAPA systems, risk management processes, and compliance remediation programs.
Strategic leadership with the ability to influence all levels of the organization.
Strong business acumen and ability to balance compliance requirements with operational objectives.
Exceptional proactive problem-solving, risk assessment, and decision-making capabilities.
Strong project and change management skills.
Excellent verbal, written, presentation, and executive communication skills.
Proven ability to lead cross-functional teams and drive organizational change.
Highly collaborative with strong stakeholder management capabilities.
Ability to successfully manage multiple priorities in a dynamic, fast-paced regulated environment.
Results-oriented with a strong commitment to quality, compliance, patient safety, and continuous improvement.

Nice To Haves

An advanced degree is preferred.
ASQ Certified Quality Auditor (CQA), Certified Quality Manager (CMQ/OE), Six Sigma Green Belt or Black Belt preferred.

Responsibilities

Provide strategic leadership and governance for the site Quality Management System, ensuring compliance with applicable regulatory requirements and industry standards.
Establish and maintain quality policies, procedures, standards, and governance processes to ensure a compliant and effective quality system.
Collaborate with Manufacturing, Manufacturing Engineering, Purchasing, Regulatory Affairs, R&D, and Senior Leadership to ensure quality and compliance objectives are integrated into site priorities.
Support new product introductions, technology transfers, process improvements, digital transformation initiatives, and business growth strategies.
Lead continuous assessment and enhancement of the QMS to meet evolving business, regulatory, and industry expectations.
Serve as the site Quality Systems process owner for key QMS elements, including but not limited to: Third Party audits and Internal Audits, Management Review, Quality Audits, Data Integrity, Quality Metrics, Regulatory Inspection Readiness.
Develop and execute the site quality compliance strategy to ensure ongoing adherence to cGMP, ISO, ICH and applicable FDA regulations and Health Canada requirements.
Maintain site-wide inspection readiness and lead preparation activities for regulatory inspections, internal audits, and customer audits.
Ensure annual cGMP, GDP, and Data Integrity Training is conducted.
Lead, coach, develop, and mentor Quality Management System and Compliance personnel.
Serve as a key Quality Management System representative during regulatory inspections and compliance-related interactions with regulatory agencies and external auditors.
Provide strategic oversight of the Internal and Supplier Audit Program, ensuring risk-based audit planning and execution.
Ensure robust processes are in place and are inspection ready for CAPA, Change Control, Document Management, Training, Quality Risk Management.
Provide leadership and oversight and ensure timely and effective CAPAs in responses to audit observations, regulatory findings, nonconformances, and compliance commitments.
Ensure audit observations are appropriately investigated with robust root cause analysis, risk assessed and remediated through effective CAPA implementation.
Ensure risk assessments are conducted, maintained, and periodically reviewed for products, processes, systems, suppliers, and quality events.
Identify, monitor, and mitigate compliance and quality system risks through data-driven decision making and drive continuous improvement initiatives utilizing Quality Risk Management, Lean, Six Sigma, and operational excellence methodologies.
Lead enhancement and optimization of electronic Quality Management Systems (eQMS).
Establish and maintain site Quality Metrics and Key Performance Indicators (KPIs) that measure the health and effectiveness of the Quality Management System.
Lead monthly Quality Review and annual Management Review meetings.
Perform other duties as assigned.