Job Description

Job Description

The Associate Director of IT Quality Assurance will be responsible for the Quality oversight of GxP computerized solutions in accordance with applicable company procedures and policies as governed by the Quality Manual and global regulations. This position will work directly with Business Process Owners, Data Owners and Technology Support & Delivery services over the life cycle of the system. The incumbent will support the preparation, review, and approval of documentation related to validation and quality operation of computerized systems including core requirements, policies, guidelines, SOPs, quality alerts, quality bulletins, white papers, best practices, flow charts, and training with the focus on driving consistency of requirements and system functionality across global organizations.

The successful candidate will demonstrate mastery in key core competencies around leadership and teamwork, communication, problem solving and decision-making, and conflict resolution. The candidate will able to hold accountability for sound decisions by possessing a thorough understanding of Computer System Validation, industry regulation and IT operations

The Associate Director of IT Quality Assurance will be responsible for the following activities:

* Drive strategy and continuous process improvement and validation across all enterprise quality management system capabilities

* internal/external entities to evaluate, assess, identify, install and maintain technologies aligned with company Quality strategic objectives

* Provide quality & compliance consultancy and expertise to Global Quality Organization, IT and company colleagues

* Facilitate/manage multiple ad-hoc initiatives and general operational activities

* Monitor/Report service metrics (SLAs)

* Provide technical consultation/expertise/inputs to capability owners and Global Quality Organization

* Must have experience with managing employees and contractors. Serves as a role model, mentor for direct reports and shares knowledge within and across functions.

* Must be self-driven, proactive, work with minimal supervision and possess good communication skills to interact across all levels

* Interfaces with functional area representatives as well as groups to ensure timely execution of project activities, including anticipating and identifying project risks, mitigations, and contingencies as well as supporting timely action plans and issue resolution

* Monitor and communicate any decisions, proposed changes or recommendations that have a significant impact to deliverables, timelines and/or approach to the appropriate cross-functional team members and/or leadership forums

Education Minimum Requirement:

* B.S or B.A In Science, Pharmacy, Computer Science, Business Administration

Required Experience and Skills:

* At least 7 years of experience working in a quality and/or compliance oversight role in the pharmaceutical/biotech industry.

* Must demonstrate extensive knowledge of the principles, theories and concepts of computerized system validation for compliance to GxP regulations, including data integrity requirements, and SOP writing

* Prior experience with employee management

* 3 years of experience in delivering validated IT solutions or an application support role

* Familiarity and practical experience in the implementation of quality systems in a pharmaceutical or biotechnology manufacturing environment.

Preferred Experience and Skills:

* Masters or equivalent degree in pharmaceutical manufacturing or business administration

* Good understanding of Technology Operations

* Six-Sigma Green Belt Certification

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network thats committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Newco

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

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We are an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.

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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R87406