Associate Director, Quality Systems & Compliance

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.

GENERAL SUMMARY:

The Associate Director, Quality Systems and Compliance, is responsible for the oversight of the Regulatory Functions that support the Organan Teknika Facility, while actively supporting, participating in and embracing an empowered team culture.

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 Quality Compliance and Batch Release, 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

• System Owner for Change Controls

• System Owner for Complaints, Deviation Management and Document Control

• Review and approve Quality Notifications, Change Controls

• Author, review, and approve SOPs

• Performs Mock Recalls.

• Permanent Inspection Management

• 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

• Serve as the Subject Matter Expert for all Regulatory Compliance related matters

• Review and approve Operation, Technology, or Automation protocols

• Participation in Kaizen events.

Other:                                                                

• Direct support of regulatory inspections and audits.

• Direct support of validation activities and all other associated Quality functions.

• 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 unit’s 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

RESOURCE MANAGEMENT:

• Forecasts resource needs; manages allocated budget

Education Minimum Requirement:

• Bachelor’s or Master's Degree in Biology, Biochemistry, Chemistry or other relevant discipline

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

Preferred:

• Quality Control, Quality Assurance and/or cGMP experience

WORKING RELATIONSHIPS:

• Reports to Site Quality Head

• 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

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 that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time. 

Who we are …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

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.

If you need an accommodation for the application process please email us at staffingaadar@merck.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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R45276