Johnson & Johnson MedTech
Director External Quality Operations & OpEx
Johnson & Johnson MedTech, Horsham, Pennsylvania, United States, 19044
Director External Quality Operations & OpEx
Join to apply for the
Director External Quality Operations & OpEx
role at
Johnson & Johnson MedTech .
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 Attributes Job Function:
Quality
Job Sub Function:
Business Process Quality
Job Category:
People Leader
All Job Posting Locations:
Horsham, Pennsylvania, United States; Raritan, New Jersey, United States; Remote (US); Titusville, New Jersey, United States
Job Description Johnson & Johnson is currently recruiting
Director External Quality Operations & OpEx ! This position can be performed globally at any J&J location with a preference for Horsham, PA, Titusville or Raritan, NJ. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s).
Essential Job Duties And Responsibilities
Act as OpEx and Quality Operations point of contact both within P&O as well as with other EQ personnel
Coordinate with stakeholders and platform OpEx leaders to identify opportunities to transfer transactional activity work from EQ Site Quality Leads to the EQ Quality Operations team, evaluate business case of improvement initiatives, prioritize needs/ideas, track progress, and quantify benefits realized.
Continuous optimization of activities within the Quality Operations and OpEx remit
Facilitate connections between platforms for opportunities, input on changes, sharing best practices, and alignment on improvement initiatives
Process owner for EQ business processes e.g. Budget
Shape, monitor for trends, define and oversee actions from same and report EQ level metrics
Lead a team of approximately 20 people
Lead the team to foster growth and learning, enabling them to perform at their optimum. Provide support in items that require input, clarification or escalation
Provide oversight of EQ personnel engaged in the management and execution of EQ Quality Operations activities
Ensure that the EQ quality process and systems used to support Quality Operations activities are adhered to and maintained.
Manage quality compliance risks as well as business needs
Ensure issues are escalated to senior management where appropriate.
Develop and foster an environment of innovative thinking and learning, through project management, benchmarking methods, training programs, the use of Process Excellence tools, and monitoring of progress.
Perform related duties as assigned by supervisor
Maintain compliance with all company policies and procedures
Minimum Qualification Education Bachelor’s Degree in engineering, science, or an equivalent technical discipline.
Required
A minimum of 10 years working in a regulated environment
Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production
Ability to effectively apply project management tools and lean methodologies when leading projects and programs is required.
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.
Experience with External Quality processes and procedures
Understands and shapes strategic objectives of the External Quality organization and finds ways to implement these strategies in daily activities. Helps others understand and apply organizational objectives.
Is viewed as a trusted partner across the business, anticipates additional needed relationships and proactively takes actions; leverages relationships; develops strategic alliances.
Proven ability in leading teams.
Exceptional creative and critical thinking, excellent decision‑making and analytical abilities are required.
Big‑picture orientation with attention to detail and results‑oriented are required.
Ability to work in a matrix and multi‑cultural environment required.
Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers. Proficiency in English is required.
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.
Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.
Required Skills Preferred Skills
Business Alignment, Business Process Management (BPM), Business Requirements Analysis, Compliance Management, Developing Others, Fact‑Based Decision Making, Inclusive Leadership, ISO 9001, Leadership, Managerial Courage, Process Governance, Process Optimization, Quality Control (QC), Quality Standards, Quality Validation, Resource Management, Six Sigma, Standard Operating Procedure (SOP), Tactical Thinking
Pay Transparency The anticipated base pay range for this position is: $146,000–$251,850 USD.
Subject to the terms of their respective plans, employees and/or eligible dependents are 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 are 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 may be eligible for the following time‑off benefits: Vacation – 120 hours per calendar year; Sick time – 40 hours per calendar year (56 hours for Washington State residents); Holiday pay, including Floating Holidays – 13 days per calendar year; Work, Personal and Family Time – up to 40 hours per calendar year; Parental Leave – 480 hours within one year; Condolence Leave – 30 days for an immediate family member, 5 days for an extended family member; Caregiver Leave – 10 days; Volunteer Leave – 4 days; Military Spouse Time‑Off – 80 hours. Additional information can be found through the link below:
https://www.careers.jnj.com/employee-benefits .
Equal Opportunity Employer Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via
https://www.jnj.com/contact-us/careers
or contact AskGS to be directed to your accommodation resource.
#J-18808-Ljbffr
Director External Quality Operations & OpEx
role at
Johnson & Johnson MedTech .
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 Attributes Job Function:
Quality
Job Sub Function:
Business Process Quality
Job Category:
People Leader
All Job Posting Locations:
Horsham, Pennsylvania, United States; Raritan, New Jersey, United States; Remote (US); Titusville, New Jersey, United States
Job Description Johnson & Johnson is currently recruiting
Director External Quality Operations & OpEx ! This position can be performed globally at any J&J location with a preference for Horsham, PA, Titusville or Raritan, NJ. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s).
Essential Job Duties And Responsibilities
Act as OpEx and Quality Operations point of contact both within P&O as well as with other EQ personnel
Coordinate with stakeholders and platform OpEx leaders to identify opportunities to transfer transactional activity work from EQ Site Quality Leads to the EQ Quality Operations team, evaluate business case of improvement initiatives, prioritize needs/ideas, track progress, and quantify benefits realized.
Continuous optimization of activities within the Quality Operations and OpEx remit
Facilitate connections between platforms for opportunities, input on changes, sharing best practices, and alignment on improvement initiatives
Process owner for EQ business processes e.g. Budget
Shape, monitor for trends, define and oversee actions from same and report EQ level metrics
Lead a team of approximately 20 people
Lead the team to foster growth and learning, enabling them to perform at their optimum. Provide support in items that require input, clarification or escalation
Provide oversight of EQ personnel engaged in the management and execution of EQ Quality Operations activities
Ensure that the EQ quality process and systems used to support Quality Operations activities are adhered to and maintained.
Manage quality compliance risks as well as business needs
Ensure issues are escalated to senior management where appropriate.
Develop and foster an environment of innovative thinking and learning, through project management, benchmarking methods, training programs, the use of Process Excellence tools, and monitoring of progress.
Perform related duties as assigned by supervisor
Maintain compliance with all company policies and procedures
Minimum Qualification Education Bachelor’s Degree in engineering, science, or an equivalent technical discipline.
Required
A minimum of 10 years working in a regulated environment
Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production
Ability to effectively apply project management tools and lean methodologies when leading projects and programs is required.
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.
Experience with External Quality processes and procedures
Understands and shapes strategic objectives of the External Quality organization and finds ways to implement these strategies in daily activities. Helps others understand and apply organizational objectives.
Is viewed as a trusted partner across the business, anticipates additional needed relationships and proactively takes actions; leverages relationships; develops strategic alliances.
Proven ability in leading teams.
Exceptional creative and critical thinking, excellent decision‑making and analytical abilities are required.
Big‑picture orientation with attention to detail and results‑oriented are required.
Ability to work in a matrix and multi‑cultural environment required.
Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers. Proficiency in English is required.
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.
Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.
Required Skills Preferred Skills
Business Alignment, Business Process Management (BPM), Business Requirements Analysis, Compliance Management, Developing Others, Fact‑Based Decision Making, Inclusive Leadership, ISO 9001, Leadership, Managerial Courage, Process Governance, Process Optimization, Quality Control (QC), Quality Standards, Quality Validation, Resource Management, Six Sigma, Standard Operating Procedure (SOP), Tactical Thinking
Pay Transparency The anticipated base pay range for this position is: $146,000–$251,850 USD.
Subject to the terms of their respective plans, employees and/or eligible dependents are 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 are 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 may be eligible for the following time‑off benefits: Vacation – 120 hours per calendar year; Sick time – 40 hours per calendar year (56 hours for Washington State residents); Holiday pay, including Floating Holidays – 13 days per calendar year; Work, Personal and Family Time – up to 40 hours per calendar year; Parental Leave – 480 hours within one year; Condolence Leave – 30 days for an immediate family member, 5 days for an extended family member; Caregiver Leave – 10 days; Volunteer Leave – 4 days; Military Spouse Time‑Off – 80 hours. Additional information can be found through the link below:
https://www.careers.jnj.com/employee-benefits .
Equal Opportunity Employer Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via
https://www.jnj.com/contact-us/careers
or contact AskGS to be directed to your accommodation resource.
#J-18808-Ljbffr