SENIOR MANAGER QUALITY SYSTEM SERVICES

Johnson & Johnson Vision is currently recruiting for a Senior Manager Quality System Services ! This position can be located at any Johnson & Johnson Vision Site with a preference for Irvine, CA or Jacksonville, FL.
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress.
As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good.
We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.
Every day, our more than employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.
Position Summary.
Responsible for establishing and maintaining effective Document Control, Records Management, Training Processes, and Applications/Platforms are in compliance with local, national and international regulations and standards as well as with all franchise policies and processes and J&J Corporate requirements.
Responsible for management of purchasing controls for managing supplier related systems such as change control, NC/CAPA, Quality Agreements.
Provide guidance and support to project teams regarding outsourced activities.
Influencing business partners/project teams to comply with purchasing procedures.
Responsible for integration, maintenance, and governance of the Vision Data Integrity program.
Responsible to identify and execute strategic programs and projects to elevate systems and foster innovation.
This role monitors the performance and health of the associated Quality Management Systems elements through metrics and analytics to drive enhancement and proactive compliance.
Supports departmental and business unit objectives, while adhering to the Johnson and Johnson Credo, as well as local safety and environmental policy and procedures.
Supports internal/external audits as Subject Matter Expert as well as strategy and audit support team member.
Key Responsibilities.
·       Accountable for maintaining department compliance with regulations such as, but not limited to, FDA Quality system Regulation 21 CFR Parts 820; ISO , FDA Combo Regulation 21 CFR Parts 4; Current Good Manufacturing Practice (CGMP) regulation 21 CFR , and international regulatory requirements (Japanese MHLW, Brazilian ANVISA).
·       Lead, mentor and develop staff members and self.
·       Provide ownership and leadership of processes and platforms across JJV.
·        Accountable to establish and maintain effective processes to assure that personnel within assigned business are equipped with the knowledge, understanding and training to successfully execute their responsibilities to the highest of standards.
·       Actively engages and drives collaboration across JJV, MedTech and Enterprise.
·       Monitor and identify trends and take corrective action as appropriate to maintain a high level of compliance.
·       Develop initiatives are focused and aligned with the organizational goals & objectives.
·       Acts as subject matter expert, identifying areas of improvement and making recommendations that positively impact the QMS.
·       Perform other work-related activities assigned by management.
Qualifications Education.
A minimum of a Bachelor’s or equivalent University degree is required, with a focus in Science, Engineering or Business preferred.
Required Skills.
·       Minimum 8-10 years related experience in Quality, Regulatory, Supplier Quality, or a regulated industry, and a minimum of 5 years in a management or supervisory role.
·       Ability to effectively manage people (both directly and indirectly) and manage projects that include cross-functional teams representing diversified areas.
·       Thorough knowledge of 21 CFR 820 and ISO at a minimum.
·       Experience developing and implementing digital solutions that are DI compliant.
·       Working knowledge of international medical device quality system requirements.
·       Demonstrated success in leadership development.
·       Demonstrated ability to handle multiple projects and discern major quality issues.
·       Proven track record and strong leadership capabilities ·       Has direct supervisory responsibilities for a department or function.
·       Knowledgeable of a broad set of regulations and standards (e.
., 21 CFR ; ISO ; etc) ·       Skills.
Detail oriented, people leader, quick learner, team player ·       Abilities.
Critical thinking, strong communication and negotiation skills, ability to lead others.
·       Certifications.
None required; digital technology, data integrity and compliance certifications preferred ·       Affiliations.
ASQ or RAPS preferred ·       Other.
Under general or minimum supervision, performs duties in terms of stated objectives.
Generally, works out details within broad guidelines and exercises considerable initiative and judgment.
·       Other.
·       This position may require up to 25% domestic & international travel.
·       This position has an estimated annual salary of USD$       - Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs.
medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
·       Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
·       This position is eligible to participate in the Company’s long-term incentive program.
- Employees are eligible for the following time off benefits.
- Vacation – up to 120 hours per calendar year - Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year - Holiday pay, including Floating Holidays – up to 13 days per calendar year - Work, Personal and Family Time - up to 40 hours per calendar year.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
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