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  • ID
    #43752379
  • Salary
    TBD
  • Source
    Merck
  • Date
    2022-07-01
  • Deadline
    2022-08-30
 
Full-time

Vacancy expired!

Job DescriptionOur team is within our Research & Development Division's Quality Assurance, Global Development Quality organization and is responsible for oversight of manufacturing activities for the Clinical Supply Chain. Partnering across our internal facilities and external contract manufacturers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. We are looking for strong leaders with an international and cross-functional mindset, strong stakeholder management skills, the ability to maintain and develop strong working relationships with network leaders and progress our systems and process development to the next level.The Associate Director, Clinical Supplies Quality Operations & Technology, plays a critical role leading the enabling functions within Quality in support of the Clinical Supply Chain. The key duties of the Quality Operations & Technology team include development and support for Clinical Supply Chain Strategy, Quality Planning, Medical Device/Combination Products and New Technologies, Global SAP Process Stewardship for our Research & Development Division Quality, Management of Quality Events and Development of Business Tools and Data Analytics for Global Development Quality. Additionally, the team drives innovation and digitalization of our processes thereby enabling speed and reliability for clinical supplies disposition. The team partners closely with the key stakeholder groups including Global Clinical Supplies, Development Quality, Regulatory Affairs, Global Clinical Trial Operations, Device Development and our IT team as well as multiple Quality Assurance sites and functions within the clinical supply chain.Primary Assignments:Development and execution of Quality and key stakeholder strategies, improvement initiatives in line with business drivers and objectives whilst streamlining processes and procedures and leveraging technology.

Closely collaborate with appropriate business/operations areas to ensure that effective and robust Quality systems and processes are in place.

Ensuring the reliability of clinical supplies availability for our Company's clinical trials via development of business processes, tools and data analytics, with the associated potential for high impact to the development portfolio.

Provision of in-depth technical / quality expertise regarding interpretation of data, development of metrics, identification of trends and/or potential compliance gaps and proactively leading the resolution.

Global SAP Process Stewardship for our Research & Development Division QA including process development and improvement, providing expertise and guidance and ensuring consistent application of functionality for the Quality teams supporting the end-to-end Clinical Supply Chain as well as oversight of SAP Quality master data.

Process ownership, development and management of high profile and high impact significant quality events related to clinical supplies including fact-finding, investigation, coordination of clinical quarantine and recovery actions involving cross-functional interactions with diverse groups at senior levels.

Education:Bachelor's Degree in Engineering, Biology, Chemistry or related field.

A minimum of 8+ years of relevant experience within the pharmaceutical industry or 6+ years with advanced degrees.

Preferred Experience and Skills:Strong comprehension of regulatory agency regulations and requirements coupled with proficiency in interpreting and applying current Good Manufacturing Practices (cGMPs) to our Research & Development environment.

Strong technical expertise in our Research & Development activities specifically related to clinical supplies, Medical Device/Combination Products, design and implementation of new technologies etc.

Knowledge of continuous improvement and project management methodologies; ability to lead matrix teams and direct complex cross-functional initiatives, recognize improvement opportunities, develop appropriate solutions and follow through on implementation.

Demonstrated leadership, including strategy development / deployment and background with tangible delivered benefits.

Demonstrated experience in quality risk management in the pharmaceutical industry.

Strongly developed cross-functional teamwork, collaboration, influencing and negotiation skills.

Demonstrated excellence of skill in communicating (oral and written) effectively with diverse individuals/groups at all levels.

Computer skills; knowledge and competency in ERP/MES, Trackwise, PowerPoint, Excel and Word.

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., Rahway, 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 …Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.NOTICE FOR INTERNAL APPLICANTSIn 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.New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.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/OFCCPEEOSupplementFinalJRFQA508c.pdf)Pay Transparency NondiscriminationWe 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 CarefullyMerck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:Remote WorkShift:1st - DayValid Driving License:Hazardous Material(s):Number of Openings:1Requisition ID: R189787

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