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

Primary Responsibilities

Annual Product Review

* Accountable for the management, coordination and execution of the Annual Product Review Program

* Completes holistic analysis of product performance trends and shifts, linking various aspects to product performance to identify actions to be taken to drive improved compliance performance

Health Authority Reporting

* Coordinate and execute the Health Authority Reporting process at the site, ensuring Field Alert Reports (FARs) and Biological Product Deviations Reports (BPDRs) are submitted to the US FDA in accordance with the required timeframe

Management Review of Medical Devices and Combination Products

* Coordinates/executes the Management Review of Medical Devices and Combination Products at the Wilson site including the Quarterly Tracking and Trending and the Annual Management Review

Other Responsibilities

* Updates the Site Master file as needed to make sure it is kept up to date

* Manages Deviations and Investigational activities

* Manages Change Controls

* Proactively monitors trends and recommends corrective actions to cease performance issues

* Participates in Internal and external GMP audits and inspections

* Manages the QMS system ownership program for the site, including system owner

* Participates in policy, guidelines and procedures development activity both locally and with the Manufacturing Division compliance experts externally. Interprets our Company Quality policies, GMP's and other agency regulations for application to Wilson Operations

* Provides Quality Assurance review and approval of all GMP-related SOPs

* Develops programs/procedures to improve compliance status of Wilson operations, including investigations and GMP audits

* Leads implementation of new programs/regulations/divisional processes at the site

* Drives continuous improvement (business and compliance excellence) through the use of lean six sigma methodology and identification of improvement opportunities

* Drives partnership and engagement across functions both internally and externally to implement improvement and participates and leads divisional teams focused on improvement

* Sets compliance direction for the QMS topics under his/her responsibility

* Demonstrate leadership by maintaining a safe workplace and identifying actions to prevent safety incidents

Education Minimum Requirements

* Bachelor's degree in science, engineering, or related areas of study.

Required Experience and Skills

* Minimum of five (5) years in a GMP pharmaceutical manufacturing facility with either direct involvement in Quality functions supporting release and compliance activities or indirect involvement in Quality functions through execution of activities such as: batch record/documentation reviews | investigations | corrective actions | complaints | quality system management, etc.

* Experience in technical writing.

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):

No

Number of Openings:

1
Requisition ID:R85029