Director, Integrated Product Information & Change Control

  • Whitehouse Station, NJ

Employment Type

: Full-Time

Industry

: Executive Management



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Job Description

Our Supply Chain team ensures inventory is consistently available to meet customer demand. We coordinate all aspects of supply through supply planning, sourcing, making, inventory management, packaging and delivery. We partner across the Marketing, Finance and Manufacturing organizations to build a robust demand and supply plan and ensure we get products to the right customer, at the place, at the right time.

Director, IPI Change Control will work with the IPI (Integrated Product Information) team and stakeholders to develop and deploy a new Change Control QMS and a new Change Control IT platform as part of IPI Release 2.0.

Primary Responsibilities:

* Guide the IPI Change Control workstream through development of a streamlined E2E change control process integrated with an intuitive Change Control IT platform
* Collaborate with the IPI User Council to ensure that the new process and platform meet the needs of the business and delivers an improved user experience.
* Partner with stakeholders to seamlessly connect IPI with affiliated topics (e.g. Material Control, Batch Disposition, Regulatory processes, etc.).
* Deliver a simplified QMS document structure for change control procedures and work instructions.
* Play a key role in planning and execution for deployment of the new QMS, including focus on CEM to ensure the organization is appropriately prepared to sponsor and adopt the new standard
* Develop KPI's and value realization measures to monitor installation effectiveness and sustainment performance of the new process.
* Coach and mentor team members to deliver right-first-time and on schedule each of the elements required for IPI Release 2.0

This position represents an exciting opportunity for a strong leader to make meaningful contributions to the delivery of a more efficient and effective change control process. A robust and sustainable change management process is critical to ensure compliance with regulatory dossiers and compliant supply. The selected candidate will work will stakeholders across the globe and become an integral part of our Manufacturing Division's digitalization journey.

This role can be based at any of our company's US locations, and remote work is also available.

Education Minimum Requirement:

* Bachelor degree in Science or Engineering; Master's degree or MBA are preferred.

Required Experience and Skills:

* A minimum of 15 years of experience in operational roles (e.g. Production, Technology, Supply Chain, Quality) in a regulated healthcare industry, either medical device or pharmaceutical.
* Demonstrated strength in interpersonal relations and collaboration to effectively work across functions, regions and business units.
* Demonstrated experience in leading successful Business Process Improvement initiatives, with examples of hard business benefit deployed.
* Excellent communication and influencing skills. Creative/innovative mindset, with demonstrated ability to \"think outside the box\".
* Willingness to obsess over the details and aesthetic that will ensure a user experience that 'delights'.
* Strong project management skills, inclusive of effective meeting facilitation and presentation skills, with a track record of successful execution.
* Knowledge of the major Quality Management Systems (e.g. Change Control) and the associated cGMP Regulations.

Preferred Experience and Skills:

* Identify, facilitate and lead enterprise wide, complex process improvement programs utilizing LEAN/Six Sigma methodologies to design and improve processes that deliver business strategies and performance objectives.
* Knowledge or experience with enterprise platforms, for example - TrackWise, ERP, PLM, HRM, MES, LIMS.

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 ...@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:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Flex Time, Remote Work, Telecommuting

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality


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