Sr Mgr Quality Assurance

About the role

Directs the Jacksonville, Florida Johnson & Johnson Surgical Vision Quality Operations organization, ensuring compliance with quality requirements, continuous supply to customers, and adherence to regulatory agency requirements. Leads short- and long-term strategies for the Jacksonville facility, with direct accountability over incoming raw material inspection and release, in-process and final quality inspection and testing, and oversight of the Quality Engineering team and Quality Systems site execution. Collaborates with Franchise Quality and cross-functional Supply Chain teams (Operations, Molds Engineering, Production Planning, Logistics, Product Management) to align resources and prioritization.

Responsibilities

• Serves as local Quality Systems Management Representative for the Jacksonville intraocular lens site.
• Provides tactical leadership within operations to ensure practical and timely quality decision-making and oversees day-to-day quality activities.
• Makes decisions on non-conforming material in accordance with Quality System procedures.
• Evaluates and elevates quality events to the Risk Management Board and/or Quality Board as required.
• Develops the site operational Quality strategy as a business partner to Supply Chain Operations and Franchise QA, optimizing performance, compliance, and quality systems while aligning goals across the organization.
• Hosts third-party audits and participates in Quality and Compliance Executive Reviews, Management Reviews, and Quality Boards.
• Reports to Executive Management on the effectiveness of the Quality Management System and improvement needs.
• Ensures regulatory and Quality Management Systems awareness across the organization and that required processes are documented.
• Evaluates Jacksonville Quality Operations capabilities, identifies gaps, and recommends resolutions to Executive Management.
• Develops and leads innovative initiatives to improve business performance and support visionary change.
• Provides coaching, staff development, performance management, succession planning, and departmental budget oversight.
• Acts as a technical expert with conceptual knowledge across all quality functions and business areas.
• Serves as Subject Matter Expert for Quality Systems execution during inspection readiness activities.
• Supports communications with FDA related to follow-ups of inspections at the Jacksonville site.
• Directly supports the design and deployment of Quality Systems improvements, standards, and policies at the site level.
• Ensures compliance with Company Environmental, Safety, and Industrial Hygiene policies and regulations.

Experience & Education

• Bachelor’s Degree in Science or Engineering; MBA preferred.
• 15 years of experience in Medical Devices or Pharmaceuticals, including at least 7 years in managerial roles and 5 years in Quality.
• Experience with FDA/Notified Body agencies and regulatory requirements, including US Class III (PMA) and Class II regulations, supporting timely and compliant submissions, inspections, and audits.

Required Knowledge, Skills, Abilities, Certifications/Licenses and Affiliations

• Thorough knowledge of 21 CFR 820.
• Demonstrated success in designing and deploying innovative quality systems.
• Ability to influence at senior levels and across functions, building strong internal and external networks.
• Experience delivering results through influence in a highly matrixed environment.
• Strong track record motivating, leading, and developing staff in a dynamic environment.
• Comprehensive understanding of Process Excellence, Statistical Process Control, and Applied Statistics.
• Six Sigma experience.

Preferred Skills

• Business Alignment
• Collaboration
• Compliance Management
• Fact-Based Decision Making
• Good Manufacturing Practices (GMP)
• ISO 9001
• Mentorship
• Organizing
• Quality Auditing
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Quality Validation
• Regulatory Environment
• Standard Operating Procedure (SOP)
• Tactical Thinking
• Technical Credibility

Pay

The anticipated base pay range for this position is $122,000.00 – $212,750.00.

Benefits

• Consolidated retirement plan (pension) and 401(k) savings plan participation, subject to plan terms.
• Eligibility for the Company’s long-term incentive program.
• Vacation: 120 hours per calendar year.
• Sick time: 40 hours per calendar year; 48 hours for Colorado residents; 56 hours for Washington residents.
• Holiday pay including Floating Holidays: 13 days per calendar year.
• Work, Personal and Family Time: up to 40 hours per calendar year.
• Parental Leave: 480 hours within one year of childbirth/adoption/foster care.
• Bereavement Leave: 240 hours for an immediate family member; 40 hours for an extended family member per calendar year.
• Caregiver Leave: 80 hours in a 52-week rolling period.
• Volunteer Leave: 32 hours per calendar year.
• Military Spouse Time-Off: 80 hours per calendar year.