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Director External Quality Operations & OpEx

Director External Quality Operations & OpEx

J&J Family of CompaniesWashington Crossing, PA, US
3 days ago
Job type
  • Full-time
Job description

Director External Quality Operations & OpEx

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.

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 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. This role is responsible for overseeing a diverse, global team that manages the transactional execution of EQ Quality activities, establishing and overseeing OpEx activities as well as ownership of EQ business processes like budget management. This role monitors and identifies trends in key quality metrics, budget and resource management and will be a mix of hands-on leadership to support day to day activities while utilizing a strategic mindset to ensure long term success.

  • 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

  • Provides oversight of EQ personnel engaged in the management and execution of EQ Quality Operations activities
  • Ensures that the EQ quality process and systems used to support Quality Operations activities are adhered to and maintained.
  • Manages quality compliance risks as well as business needs
  • Ensures issues are escalated to senior management where appropriate.
  • Develops and fosters 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.

    • 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.

    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

    The anticipated base pay range for this position is : $146,000-$251,850 USD

    Additional Description for Pay Transparency : 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. Subject to the terms of their respective plans, 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. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits : Vacation 120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year 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 of the birth / adoption / foster care of a child 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.

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