Sr Manager Quality Operation

Confidential Careers; Florida; On-site; USD 180,000 - 240,000; Full time

Job summary

Confidential Careers in Florida seeks an experienced Quality Operations leader to drive cGMP compliance and regulatory readiness at an FDA-regulated manufacturing facility. The senior role oversees QA, QC, batch disposition, investigations, CAPA and inspections, partnering with Operations, Engineering, R&D and Supply Chain to ensure safe, high-quality OTC products and sustained regulatory readiness.

You will build a high-performing team, influence senior stakeholders, and lead continuous

Qualifications

• 12+ years of progressive quality leadership in FDA-regulated manufacturing.
• Experience leading Quality Operations at an OTC drug facility under cGMP.
• Proven success in FDA/Health Canada inspections and remediation.

Responsibilities

• Provide strategic and operational leadership for QA, QC, batch disposition, and finished-product release.
• Lead site preparation for regulatory inspections and responses to observations.
• Oversee CAPA, investigations, change control, and validation activities.
• Build a high-performing Quality organization and partner with cross-functional teams.

Skills

Quality leadership

Regulatory compliance

cGMP experience

Regulatory inspections

Quality systems

Cross-functional leadership

Data-driven decisions

Education

Bachelor's degree in Chemistry/Microbiology/Pharmacy/Engineering

Advanced technical or business degree preferred

Job description

A leading consumer healthcare manufacturer is seeking an experienced Quality Operations leader to oversee quality and regulatory compliance at an FDA-regulated manufacturing facility in Florida.

This senior leadership role is accountable for product quality, current Good Manufacturing Practice (cGMP) compliance, regulatory inspection readiness, and the overall effectiveness of the site's Quality Management System. The successful candidate will lead the site's Quality organization and partner closely with Operations, Engineering, Research & Development, Supply Chain, and other business functions to ensure the consistent manufacture and release of safe, high-quality over-the-counter (OTC) drug products.

The ideal candidate brings extensive experience leading Quality Operations in a regulated pharmaceutical or OTC drug manufacturing environment, along with a demonstrated track record of managing regulatory inspections, addressing significant compliance deficiencies, and implementing sustainable remediation programs. This individual must be comfortable making independent quality decisions, influencing senior stakeholders, and building a culture of accountability, transparency, and continuous improvement.

Key Responsibilities

Quality Leadership and Compliance

• Provide strategic and operational leadership for all site Quality functions, including Quality Assurance, Quality Control, incoming material controls, in-process controls, batch disposition, and finished-product release.
• Maintain sustained compliance with applicable FDA cGMP regulations, including 21 CFR Parts 210 and 211, Health Canada requirements, and internal quality standards.
• Serve as the senior site Quality leader and primary quality interface with regulatory agencies, including the FDA and Health Canada.
• Maintain a robust Quality Management System that supports product integrity, consistent manufacturing performance, and ongoing regulatory compliance.
• Exercise independent quality oversight and decision-making authority over product quality, batch disposition, deviations, investigations, corrective and preventive actions (CAPA), change control, validation, complaints, and related quality-system activities.

Regulatory Inspections and Remediation

• Lead site preparation for and execution of announced and unannounced regulatory inspections, including inspection planning, document management, subject-matter-expert preparation, inspection-room coordination, and daily governance.
• Direct the development and execution of timely, scientifically sound, and evidence-based responses to FDA Form 483 observations, Health Canada findings, and other regulatory commitments.
• Lead remediation programs addressing regulatory observations, audit findings, product-quality concerns, and systemic compliance deficiencies.
• Establish clear remediation workstreams, milestones, accountability, effectiveness measures, and escalation protocols to ensure sustainable resolution of compliance issues.
• Communicate regulatory risk, remediation progress, and outstanding commitments to site and senior leadership.
• Independently escalate significant or unresolved product-quality, data-integrity, and regulatory-compliance risks.

Quality Systems and Technical Excellence

• Strengthen investigation and CAPA processes through effective root-cause analysis, timely execution, and documented verification of effectiveness.
• Ensure data integrity and appropriate controls across paper-based and electronic GxP systems, including documentation, audit trails, access, review, retention, and escalation.
• Oversee laboratory operations, analytical methods, specifications, stability programs, out-of-specification and out-of-trend investigations, and microbiological and chemical testing.
• Ensure appropriate quality oversight of validation, equipment and facility qualification, process changes, cleaning processes, and contamination-control practices.
• Lead Quality Management Reviews and establish meaningful performance metrics to monitor compliance, identify emerging risks, and drive continuous improvement.
• Provide quality leadership for new products, process transfers, capital investments, technology changes, and site improvement initiatives.
• Oversee supplier quality and external service providers, including qualification, performance monitoring, investigations, and corrective-action follow-through.

Leadership and Cross-Functional Partnership

• Lead, develop, and retain a high-performing Quality organization through coaching, clear expectations, performance management, succession planning, and technical development.
• Build strong partnerships with Operations, Engineering, R&D, Regulatory Affairs, Supply Chain, IT, Legal, and other stakeholders to integrate quality into daily decision-making.
• Promote a proactive quality culture centered on prevention, compliance, transparency, accountability, and timely escalation.
• Manage the site's Quality budget and resource plan, including staffing, laboratory capabilities, external expertise, and remediation support.
• Establish effective governance, procedures, training, and communication processes that reinforce quality standards throughout the facility.

Qualifications

Education

• Bachelor's degree in Chemistry, Microbiology, Pharmacy, Engineering, or a related technical discipline required.
• Advanced technical or business degree preferred.

Professional Experience

• Typically 12 or more years of progressive experience in Quality and Quality leadership within FDA-regulated pharmaceutical or OTC drug manufacturing.
• Significant experience leading Quality Operations at a manufacturing facility producing OTC drug products under cGMP requirements.
• Demonstrated success leading FDA and/or Health Canada inspections, including inspection preparation, execution, regulatory responses, commitments, and post-inspection follow-up.
• Documented experience resolving significant regulatory compliance issues and leading complex remediation initiatives through sustainable closure.
• Extensive knowledge of pharmaceutical quality systems, including investigations, CAPA, change control, validation, laboratory controls, data integrity, complaints, batch disposition, and supplier quality.
• Experience leading multidisciplinary teams and influencing senior stakeholders in a complex manufacturing environment.
• Strong executive presence, judgment, and decision-making skills, with the ability to maintain independent quality oversight under pressure.
• Exceptional written and verbal communication skills, including preparation of regulatory responses and presentation of compliance risks to senior leaders and regulators.
• Proven ability to manage multiple high-priority initiatives, remediation workstreams, deadlines, external consultants, and cross-functional teams.
• Demonstrated ability to develop talent, establish accountability, and influence a culture of quality and compliance.
• Strong organizational, analytical, and project-management skills.
• Lean, Six Sigma, or a relevant professional quality certification is a plus.

Work Environment and Location

• Work arrangement: 100% on-site; this position requires a consistent physical presence at the manufacturing facility.
• Limited travel may be required for supplier or contract-site visits, training, corporate meetings, and regulatory support.
• Occasional availability outside normal business hours, including nights or weekends, may be necessary to support manufacturing operations and urgent quality matters.
• The role operates in a fast-paced manufacturing environment and requires regular interaction with production teams and timely, risk-based decision-making.
• Compliance with applicable environmental, health, safety, and quality procedures is an essential responsibility.

This is an opportunity for an experienced Quality leader to make a meaningful impact on manufacturing performance, regulatory compliance, product quality, and organizational effectiveness. The successful candidate will have the opportunity to strengthen quality systems, develop a high-performing team, and partner across the business to sustain a culture of quality and continuous improvement.