Manager Quality Operations

Johnson & Johnson•Titusville, NJ

2d•$102,000 - $177,100

About The Position

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 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 humanity. Learn more at https://www.jnj.com Job Function: Quality Job Sub Function: Quality Assurance Job Category: People Leader All Job Posting Locations: Beerse, Antwerp, Belgium, Horsham, Pennsylvania, United States of America, Latina, Italy, Ringaskiddy, Cork, Ireland, Schaffhausen, Switzerland, Titusville, New Jersey, United States of America 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

Requirements

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.

Nice To Haves

Other languages than English are a benefit.

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.
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