Director, Technical Operations - Global Clinical Supply (GCS)

MSD•Rahway, PA

8d•Hybrid

About The Position

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

Requirements

Bachelor's degree in an engineering, scientific, or related field.
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.
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
Establishing Contacts
Estimation and Planning
GMP Compliance
Inspection Readiness
Integrated Product Teams
Intercultural Collaboration
Leadership
Maintenance Supervision
Management Process
Manufacturing Scale-Up
Operations Management
Pharmaceutical Management
Pharmaceutical Packaging

Nice To Haves

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

Responsibilities

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