Job Description

Position Overview

The Associate Director is an important Business and Operations Leader within the Integrated Process Team (IPT) at the Wilson, NC Packaging & Device Assembly Site, providing strategic and operational guidance to a team of professionals. Responsibilities for this position will include coordinating engineering activities in support of our operations and organizational objectives, providing vision and direction, along with application of structured problem solving tools for investigation, event resolution, and continuous improvement. In addition, the position will be accountable for various compliance related activities, including assumption of key roles within the quality management systems to strengthen compliance and inspection readiness in areas including manufacturing and packaging production controls, medical device design control and transfer, quality risk management, change control, and deviation & complaint management.

This individual will influence important business decisions that ensure successful operations and business outcomes, in accordance with established procedures, adhering to all domestic and international quality, safety, and environmental guidelines. They will manage a portfolio of projects or initiatives that are prioritized and resourced to deliver key business goals for the IPT and the site. They will provide technical and process direction and support to a technical team and to our production operations team in a wide range of capacities ranging from analysis of operating performance, management of key operational data within SAP, application of advanced problem solving, and data-driven decision-making. They will strategically and tactfully integrate programs, processes, and ideas that support employee engagement and development across all levels of the organization.

Primary Activities

• Utilize a high degree of independent judgment and decision-making to direct production, engineering or support operations personnel to ensure customer supply requirements are achieved in a manner that is sustainable and cost-efficient.
• Drive compliance activities to include quality chapter ownership, defect elimination, procedure writing and development, coordinate deviation response activities.
• Assume direct oversight of engineering resources to drive continuous improvement, event investigation/management, and project management activities.
• Build and enhance standards for analyzing line performance and metrics; collaborate with production planners, coaches, engineering, and maintenance teams to drive efficient utilization of manufacturing assets.
• Review volumes, determining opportunities and risks and defining performance targets.
• Act as central point of contact for the IPT; lead and support continuous improvement projects (Lean, Constraint management, Continuous Improvement).
• Monitor IPT project portfolio in conjunction with cross-funcitonal teams to ensure effective prioritization, project management, and issue escalation.
• Facilitate development and review of staffing levels versus Operating Plan to identify gaps and corrective measures.
• People manager - manage employee performance and facilitate employee engagement. Effectively coach and develop employees.
• Work closely with site leaders and people managers to discover and analyze performance gaps.

Education Minimum Requirement:

• Bachelor of Science in Engineering field

Required Experience and Skills:

• Bachelor degree or higher required in engineering field.
• Six years of relevant industry work experience, with some experience managing multi layered organization
• Experience in Continuous Improvement, Lean Manufacturing and Right First Time Methodologies
• Demonstrated strong leadership and interpersonal skills with ability to coach, influence and support others through a culture of inclusion, feedback and empowerment
• Demonstrated ability to motivate people to achieve stretch goals
• Demonstrated experience using analytical, organizational and project management skills
• Strong written and verbal communication skills including experience in management of deviation investigations / technical writing
• Demonstrated ability to work independently as a team leader and team member

Preferred Experience and Skills:

• Relevant work experience encompassing a working knowledge of FDA regulatory requirements
• GMP experience in a pharmaceutical manufacturing, packaging, or device assembly environment
• SAP working knowledge
• Green or Black Belt Certification in Lean Six Sigma
• Knowledge and/or experience with formal problem solving techniques as it relates to a hands-on approach to problem solving, such as root cause analysis
• Proficiency in lean/six sigma methodology and tools, understanding of Change Execution Methodology and Behavioral Coaching and Consequence Management tools and methodology desired.
• In-depth knowledge of material flow and related control systems in a manufacturing environment
• Technical writing experience with investigations, change requests, standard operating procedures, batch records, protocols
• Demonstrated data analysis skills using advanced functionality in excel, Parsec, Microsoft access, statistical software packages (Minitab)
• Demonstrated ability to coach others in performance of job tasks in a team environment
  

Reporting Relationships:

Solid line report to: Director of Operations

Dotted line report to: N/A

Position(s) reporting to this position: Specialist, Engineering

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. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

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 presence.This 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”.

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

Search Firm Representatives Please Read Carefully
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.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

02/11/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.