Job Description

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Associate Director, Quality Technical, is responsible for leading a team that supports deviation management, change control, site qualification/validation, equipment qualification, complaints and technical support quality for sterile manufacturing of vaccines. The ideal candidate must have prior knowledge, thorough understanding of sterile manufacturing and background working with grade A,B, C and D area including isolator operation.

GENERAL PROFILE:

* Manages individual contributors (professional employees) and / or supervisors

* Contributes to the performance and results of a department

* Adapts departmental plans and priorities to address resource and operational challenges

* Decisions are guided by policies, procedures and business plan; receives guidance from manager

* Provides technical guidance to employees, colleagues or clients

* Anticipates and interprets client and / or customer needs to identify solutions

BUSINESS EXPERTISE:

* Applies management skills to align staff activities with department objectives

FUNCTIONAL EXPERTISE:

Specific to Technical Support, the Associate Director will be responsible for comprehensive management of all activities required to successfully support the site product release program to include the following:

* Lead the team and others by providing direction and guidance

* Deviation management, Review and approve Quality Notifications (QNs)

* Author, review, and approve SOPs

* Take on project management opportunities, by leading and participating in process improvement, learning events, or business support initiatives, as guided or approved by Quality management

* Train employees on new or revised processes or procedures

* Determine staffing needs and hire to meet those demands

* Review and approve Change controls, Quality Risk Management

* Serve as the Subject Matter Expert for all technical support quality related to graded area including isolator, EM, validation and qualification activities

* Serve as SME during regulatory inspection

* Must have strong expertise in SAP and other of our Company internal systems

* Review and approve Operation, Technology, or Automation protocols

* Participation in Kaizen events, lead Root cause Analysis events

* Other duties as requested by Management

PROBLEM SOLVING:

* Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units

IMPACT:

Influence

* Explains difficult concepts and persuades others to adopt point of view.

* Communicates information, asks questions and checks for understanding

Accountability

* Accountable for the performance of work group

Decision Making

* Makes decisions guided by policies and procedures that impact the units ability to meet performance objectives

* Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes

STRATEGIC PLANNING:

* Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges

* Must have continuous improvement mindset and proficiency in six sigma

RESOURCE MANAGEMENT:

* Forecasts resource needs; manages allocated budget

Education Minimum Requirement:

* Bachelors or Masters Degree in Science or Technology or related disciplines

* Minimum of 8 years experience in pharmaceutical operations, technical services, and/or quality operations with at least 5 years in a quality function

Preferred Experience and Skills:

* Operations, Quality Assurance and/or cGMP experience

* Minimum of 2 years managerial experience recommended

WORKING RELATIONSHIPS:

* Reports to Quality Director

* Manages and interacts with employees within own department

* Frequent interaction with employees from other departments

* Interacts with representatives from regulatory agencies

* Interacts with external suppliers

Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

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.

Who we are

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Invent. Impact. Inspire.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

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

Search Firm Representatives Please Read Carefully
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:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R103461