Manager Quality Operations

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech 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 more at

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Job Description:

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.

Essential Job Duties and Responsibilities

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.

The following duties and responsibilities apply based on the qualification status for each process:

• 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:

Documentation Management:

• TempTales 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

Minimum Qualification

• Bachelors 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

• Strong interpersonal and written/oral communication skills

• Proficient in applying process excellence tools and methodologies

• Excellent leadership skills. Self-starting/motivated with highly developed interpersonal and teamwork skills

• Ability to quickly process and communicate complex information and make critical decisions with limited information

• Experience influencing or persuading others to accept new ideas approaches or concepts or gains alignment on divergent issues with limited guidance.

• Knowledge of External Quality processes and procedures

• Excellent verbal and written communication skills including ability to effectively communicate with internal and external customers.

• Is viewed as a trusted partner across the business anticipates additional needed relationships and proactively takes actions; leverages relationships; develops strategic alliances.

• Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.

• Other requirements

• Other languages than English are a benefit.

• Excellent computer proficiency e.g. MS Office SAP

• Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.

• Creative and critical thinking excellent decision-making and analytical abilities are required.

Required Skills:

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The anticipated base pay range for this position is :

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