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 interlinking global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Our Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Today, we are building a new kind of healthcare company: one that is ready to help create a healthier future for all of us.

Our ability to excel hinges on the integrity, knowledge, imagination, skill, diversity, and teamwork of an individual like you. We strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you will have the opportunity to work with talented and dedicated colleagues while developing and expanding your career.

The Specialist, Quality Assurance is accountable for maintaining regulatory compliance for the supplier management systems at the Manufacturing Division in Durham, North Carolina Vaccine manufacturing facility as part of a site-wide team providing Quality oversight of supplier management systems. The role will require working closely with Quality, Procurement, Planning, Technical, Regulatory, Suppliers, and Supplier Development & Performance Management organizations at the global and local level.

Primary Responsibilities
General Profile (Multiple Independent Projects)

* Maintaining an active dialog and communicating between affected departments and leadership to ensure project progress and milestone success

* Accountable for supplier change management cases and supplier document review to ensure conformance to Manufacturing Division (MD) Standards, MD Quality Policies, cGMPs for the execution of change requests, development of Quality Agreements

* Accountable for monitoring site-supported supplier audits and coordinating audits if necessary

* Accountable for supporting site audits for supplier management systems

* Accountable for site-supported Business Continuation Memos

* Trains site system users to function within the supplier management system

* Develops and manages site supplier management system procedures while reviewing updates to divisional guidelines

* Analyzes and solves supplier management issues

* Applies team effectiveness skills, listening, and integrating diverse perspectives from across the work group to achieve team goals

Business

* Comprehends the fundamental business drivers for the company; uses this knowledge in own work

* Works in an empowered, self-directed culture with a great deal of independent decision making in the planning, coordination, and execution

* Comprehends and applies regulatory / compliance requirements relative to their role

Functional

The Specialist, Quality Assurance is accountable for activities that support regulatory and cGMP compliance programs and initiatives to include the following:

* Managing supplier change management cases and compliance documents supporting GxP systems and manufacturing processes including, but not limited to, change control documentation, vendor change notifications, Quality Agreements, and Business Continuation Memos

* Providing Quality oversight of site-supported supplier change activities to complete on schedule and in compliance with local procedures and industry standards

* Development and maintenance of robust site-wide systems as a system owner to manage supplier change-related activities

* Represents site at global level for supplier change management

* Reviews and approves SOPs and Guidelines as appropriate

* Support operational excellence initiatives targeted to increase the speed, flexibility and efficiency of processes as appropriate

* Performs special quality projects or investigations as requested by Senior Quality Management

Influence | Decision Solutions | Problem Solutions

* Influence on the continuous improvement of existing and new products at the Durham site through support of efficient, effective supplier management systems that lead to the expansion of the Durham product portfolio

* Make real time decisions in a time constrained environment

* Interactions with personnel at all levels across multiple functional areas to ensure timely completion of Quality Compliance responsibilities

Education Minimum Requirement

* Bachelor of Science degree

Required Experience and Skills

* Minimum of three (3) years of experience in GMP Change Management or equivalent system in a regulated environment

* Comprehension of FDA regulations/guidance as related to change management or supplier management

* Quality systems including change control, incident management, vendor management, and issues management

* Project or system management experience

* Working with customers understanding concerns and challenges while applying regulatory compliance and company policy guidance and maintaining excellent relationships

Preferred Experience and Skills

* B.S., B.A., or M.S. degree in Science, Engineering, or Business or equivalent experience

* Knowledge of Manufacturing processes and support systems across the Durham organization

* Knowledge of CFR, Eudralex and other regulatory guidance specific to the pharmaceutical industry

* Working with suppliers understanding concerns and challenges while applying regulatory compliance and company policy guidance and maintaining excellent relationships

* Effective analytical and problem solving skills

* Effective global communication skills (both written and verbal)

* Ability to multitask and prioritize multiple projects with deadlines

* Solution driven customer service focus

* TrackWise | SAP | Tracelink | Microsoft Excel

* Supplier transparency

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network thats devoted 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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Specified

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

None

Number of Openings:

1
Requisition ID:R71381