Manager Quality Operations

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.

Quality

Quality Assurance

People Leader

Beerse, Antwerp, Belgium, Horsham, Pennsylvania, United States of America, Latina, Italy, Ringaskiddy, Cork, Ireland, Schaffhausen, Switzerland, Titusville, New Jersey, United States of America

The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.

This position provides strategic leadership and subject matter expertise within the External Quality (EQ) team as well as to key internal and external partners to ensure the department consistently delivers pharmaceutical products that meet or exceed safety, regulatory compliance, and product standards.

• Manages team providing support in execution of the transactional activities and quality system and process troubleshooting related to EQ processes to support EQ Account Owners and members of the EQ Processes & Operations teams. Includes day-to-day problem solving and guidance. May provide direct transactional support. Primary processes in scope of day-to-day EQ Quality Operations support include:

• Temp Tales Data Analysis
• Curve Data Management (Inspections/Regulatory Actions and Field Alerts/Field Actions)
• Escalations
• NC/CAPA
• Change Controls
• Risk Management (ESQRP)
• Quality Agreements
• Account Management of External Partners
• Audit & Auditor Qualification
• Master Data
• Metrics, Data Analysis, and QSMR
• APR/PQR
• Serve as point of contact and Escalation Lead for coordination of Escalation activities on behalf of EQ Account Owners.
• Lead and facilitate periodic review meetings on behalf of EQ organization including:
• CAPA Review Board (CRB)
• Quality System Management Review (QSMR)
• Escalation Review Board (ERB)
• Optimize existing transactional support models such as EQ Audit Support Model.
• Evaluate potential expansion of current Quality Operations services. Collect stakeholder feedback and develop business cases to propose additional centralization of transactional support.
• Evaluate trends in monthly metric performance and where warranted recommend actions to drive improvements.
• Monitor Request Desk for signals and proactively propose actions to optimize performance of P&O Quality Operations team and EQ organization.
• Support in budget activities such as budget entry and cross charge management.
• Represent P&O in ongoing EQ Resource Modeling initiative.
• Provide support for Internal and External audits both as SME and a spokesperson for the specific processes.
• As required, manage non-conformance investigations either as Investigation Owner or Quality Approver.
• Coordinate with Account Owners and Platform Leaders to prioritize needs/ideas, track progress of the shared activities.
• Share metrics of the transactional processes communicating risks and successes.
• Perform related duties as assigned by supervisor.
• Maintain compliance with all company policies and procedures.

• Bachelor’s degree (or equivalent) in a scientific or technical field.
• A minimum of 6 years working in an FDA regulated environment.
• A minimum of 3 years’ experience working with pharmaceutical GMPs.
• Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production.
• Able to build connections with stakeholders and manage across cultures.