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Merck Associate Director, Clinical Supply QMS, Chapter 5 Continuum Owner in Helena, Montana

Job Description

This position reports to the Clinical Supply Quality Management System (QMS) Head, Global Development Quality and is the Clinical Supply Continuum Owner of QMS Chapters 5 (defined below) playing a key role in the design, implementation and long-term maintenance of a new QMS, including Quality Standards and Global Standard Operating Procedures, for all Clinical Supply sites performing Clinical Supply functions within the company's Global network.

In addition, the responsibilities of this position include, but are not limited to, the following:

  1. Act as a cross-functional leader and Clinical Supply subject matter expert to hold the overall responsibility for the following QMS Chapter & associated topics:

Chapter 5 – Technology Transfer and Commercialization

5.1. Technology Transfer

5.2. Validation

5.3. Expiration, Retest Dating and Stability

5.4. Shipping Qualification

5.5. Pre-approval/Pre-license Inspection Readiness

  1. Own the development, implementation and ongoing maintenance of a new Clinical Supply Continuum for the above-mentioned QMS Chapter and subtopics that is based on regulatory requirements while allowing the greatest flexibility to allow for a rapid, effective and compliant pharmaceutical development process and ensuring phase appropriate needs are considered to minimize unneeded requirements especially during early development manufacturing.

  2. Act as a change agent to stimulate, facilitate and coordinate the adaptation of the QMS redesign contributing to the overall the transformation of our company's business and culture.

  3. Accountable for identification of Clinical Supply specific requirements for responsible areas and implementation at all sites with Clinical Supply functions.

  4. Help define appropriate means for Commercialization sites in the company's network to simply and effectively operate in a hybrid Commercial and Clinical Supply space.

  5. Liaise with and leverage the expertise of commercial regulatory intelligence personnel and chapter owners, the Clinical Supply Regulatory Intelligence Lead as well as external bodies to set direction for GMP requirements for Clinical Supply areas and ensure current regulatory requirements are met using, as well as developing, industry best practices.

  6. Significantly harmonize diverse Clinical Supply site practices by developing efficient, yet flexible Global SOPs and effectively implement at all sites with Clinical Supply functions.

  7. Identify areas of continuous improvement for simple lean quality system deployment, linked to our company's Production System (MPS), ensuring best practice sharing while driving improvement within the Clinical Supply GMP network.

Position Qualifications : (please provide below)

Education Minimum Requirement:

  • Bachelor’s Degree in an appropriate scientific or engineering field of study

Required Experience and Skills:

  • Bachelor’s Degree in an appropriate scientific or engineering field of study

  • Minimum of eight (8) years’ experience in the Pharmaceutical or equivalent industry with at least 4 years within the development space

  • Strong technical knowledge, skills and experience in R&D activities, coupled with the ability to interact with technical subject matter experts on the defined QMS Chapter / Subtopics above.

  • Strong compliance mindset and knowledge of GMP regulations coupled with proficiency in interpreting and applying GMPs to a R&D environment

  • Flexibility to travel up to 10% both domestic and international

Preferred Experience and Skills:

  • Degree concentrations / fields of study: Biology, Biotechnology, Biochemistry, Chemistry, Engineering, Microbiology

  • An advanced degree

  • Experience directly related to Quality Assurance or Quality Control

  • Significant experience directly related to the development of Quality Standards and core requirements for Market Supply and / or Clinical Supply

  • Excellent verbal and written communication skills as well as presentation skills

  • Strongly developed cross-functional teamwork, collaboration, influencing and negotiating skills within and across divisions as well as within matrix organizations

  • Multiple connections within industry to keep abreast of current regulatory trends.

MRLGCTO

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

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.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Residents of Colorado

Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

EEOC GINA Supplement​

OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf)

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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:

10%

Flexible Work Arrangements:

Flex Time, Remote Work

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R115330

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