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Director, Technical Operations - Global Clinical Supply (GCS)
Director, Technical Operations - Global Clinical Supply (GCS)Merck Sharp & Dohme Corp • West Point, PA, US
Director, Technical Operations - Global Clinical Supply (GCS)

Director, Technical Operations - Global Clinical Supply (GCS)

Merck Sharp & Dohme Corp • West Point, PA, US
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Director, Technical Operations

The Director, Technical Operations within Global Clinical Supply (GCS) is responsible for technical leadership in support of GCS global facilities and equipment in collaboration with Clinical Supply Operations (CSO), Logistics and Regions, and External Partnerships & Supply (EPS). The technical lead owns business continuity of GCS facilities and equipment as well as day-to-day support of technical equipment-based challenges when required. The technical lead may also manage global infrastructure projects to establish, upgrade, and improve the GCS packaging, labeling, warehousing, and distribution network, and act as technical SME supporting next-level operational challenges with our internal and external partner operations. This individual will also collaborate regularly with upstream operations (e.g. manufacturing, devices) as well as Quality and Safety in ensuring GCS readiness to support the future pipeline.

Specifically, this role will :

  • Act as a technical lead on projects to acquire, upgrade, and modernize GCS equipment and infrastructure
  • Lead all related activities to go live with new equipment and infrastructure (e.g. Quality risk assessment, safety assessment, data integrity, change management, etc.)
  • Provide next-level support to CSO when recurring issues arise with active equipment and infrastructure
  • Ensure consistency in equipment and infrastructure requirements globally
  • Proactively evaluate, manage, and mitigate impact of new safety & quality requirements on GCS equipment and infrastructure
  • Support Permanent Inspection Readiness and Continuous Improvement expectations
  • Manage global small capital expenditures
  • Own investigations if related to active equipment and infrastructure
  • Support complex cross-functional investigations and CAPAs as a technical SME
  • Own business continuity as it relates to internal facilities and equipment for GCS
  • Partner with EPS for business continuity assessments as it relates to external packaging, labeling, and distribution
  • Provide technical support to External Partner Packaging, Labeling, Warehousing, Distribution vendors as needed
  • Partner with other functions in our Company (e.g. our Company's Manufacturing Division) to build or risk-mitigate infrastructure

Position Qualifications :

Education Minimum Requirement : Bachelor's degree in an engineering, scientific, or related field.

Required Experience and Skills :

  • At least 10 years' experience in a technical operations or related role within the pharmaceutical industry.
  • Experience with pharmaceutical packaging, labeling, warehousing, and distribution (primary packaging of solid dosage forms, secondary packaging of vaccines / biologics, medical devices).
  • Strong compliance mindset and understanding of cGMP, including FDA and EMEA.
  • Demonstrated strong project leadership of cross-functional teams through project planning, execution, monitoring and closeout phases to deliver successful completion to project target milestone dates.
  • Ability to work effectively across boundaries to build strong collaborative relations with other groups.
  • Demonstrated strategic ability to develop innovative solutions to undefined problems and business processes to meet the needs of key stakeholders and project sponsors.
  • Willing to constructively challenge the status quo and explore continuous improvement opportunities
  • Strong abilities in Stakeholder Management and building and strengthening cross-functional networks.
  • Excellent communication skills.

    • Preferred Experience and Skills :

  • Lean Six Sigma
  • Facility and equipment design requirements (e.g. safety, cross-contamination)
  • Automation / Software Development Lifecycle
  • SAP

    • Required Skills :

  • Analytical Thinking, Business Continuity, Business Performance Management, Business Processes, Business Process Management (BPM), Capital Expenditures, Change Agility, Consulting, Cross-Functional Team Leadership, Engineering Principle, Engineering Standards, Estimation and Planning, GMP Compliance, Inspection Readiness, Intercultural Collaboration, Leadership, Maintenance Supervision, Manufacturing Scale-Up, Operations Management, Pharmaceutical Management, Pharmaceutical Packaging

    • Preferred Skills :

  • Current Employees apply HERE
  • Current Contingent Workers apply HERE
  • US and Puerto Rico Residents Only : Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
  • As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.
  • As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
  • The salary range for this role is $169,700.00 - $267,200.00
  • The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
  • We offer a comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
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