Director, Technical Operations Global Clinical Supply (GCS)

Job Description

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 Companys Manufacturing Division) to build or risk-mitigate infrastructure

Position Qualifications:

• Education Minimum Requirement: Bachelors 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:

Preferred Skills:

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U.S. Hybrid Work Model

Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include 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. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

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