Johnson & Johnson MedTech · 19 hours ago
Manager Quality Operations
Horsham, PA
Full-time
Hybrid
Mid, Senior Level
$102K/yr - $177K/yr
6+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, dedicated to improving health through advanced solutions. The Manager of Quality Operations will provide strategic leadership and expertise in External Quality, ensuring compliance with safety and regulatory standards while managing a team to support quality operations.
Hospital & Health Care
Responsibilities
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
Qualification
Required
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
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
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
Preferred
Other languages than English are a benefit
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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