The position will be heavily involved in close collaboration with the contractor quality and technical personnel and interacting with their functional equivalents in Quality Disposition and Pharmaceutical Research and Development and, Procurement on strategic objectives utilizing external contractors including GMP qualification as well as site/project selection. Additionally, the incumbent would serve as the bridge between R&D and Commercialization activities and develop a strong working relationship with commercial external quality management personnel. The incumbents would be the key quality representatives attending and contributing at oversight and business review meetings with our company and contractor personnel to discuss projects, financial, operational/quality and overall performance topics.
In addition to the job specific responsibilities discussed above, the incumbents are expected to independently execute on the following:
- Plans and facilitates high risk and highly complex Quality-related process reviews and/or investigations under minimal supervision
- Provides project leadership in area of expertise in own discipline (such as leading or facilitating teams involving source area representatives in a matrix management environment.)
- Leads Quality-related reviews, cross-functional process teams and/ or investigations, serving as a subject matter expert
- Engages in strategic planning activities across the Quality Unit and directly responsible for project planning and activities of self and indirect reports associated with team activities
- Makes independent decisions and acts with authority to carry out required actions
- Coaches, mentors and develops colleagues in areas of expertise. Leads others in a matrix/management environment
- Lead the resolution of business practice, Quality and/ or compliance issues of broad scope and highest level of complexity. on cross-functional and/ or cross-divisional basis
- Identifies trends and/or potential compliance gaps and proactively leads the resolution of long-standing or significant issues affecting quality and efficiency.
- Leads communication, and serves as Quality spokesperson, on a variety of Quality or compliance-related issues.
- Interprets complex regulatory requirements for various audiences, including source area management, and facilitates communication of these requirements across stakeholders. Reviews draft policy and standards.
- Communicates with senior management within our company and the contractor organization. Facilitates and/or prepares cross-functional management presentations.
- Identifies and leads implementation of Contractor and Supplier System improvements
Education Minimum Requirement:
- Bachelor Degree in Engineering, Biology, Chemistry or related field
Required Experience and Skills:
- Bachelor’s Degree with a minimum of ten (10) years of relevant experience within the pharmaceutical industry or Advanced Degree with a minimum of eight (8) years relevant experience.
Strong scientific/ technical knowledge and experience in R&D activities, coupled with the ability to interact with scientific subject matter experts on various product initiatives and issues in the following areas: Clinical Packaging and Labeling, Distribution
25% travel is required (both domestically and internationally)
Preferred Experience and Skills:
- Strong compliance knowledge of GMP regulations coupled with proficiency in interpreting and applying GMPs to a R&D environment
- Strong understanding of regulatory agency regulations and requirements
- Strong scientific/ technical expertise, perspective and judgment in the selected subject matter area coupled with the ability to interact with scientific subject matter experts on various product initiatives.
- Ability to independently interact with regulatory officials and external auditing parties
- Possess deep drug development knowledge; demonstrated ability to facilitate training and learning in colleagues and apply knowledge to enhance the drug development process.
- Demonstrated knowledge of continuous improvement methodologies; ability to lead matrix teams, recognize improvement opportunities, develop appropriate solutions and follow through on implementation
- Strategic view of project issues in a Quality Systems environment
- Strongly developed cross-functional teamwork, collaboration, influencing and negotiation skills
- Demonstrated skills in communicating (oral and written) effectively with diverse individuals/ groups
- Demonstrated skills in leading; operational planning (3 mos to 1 year span); integrating, managing, and/or coordinating similar/ related teams, units, work processes or functions.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And 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 …
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.
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.
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We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
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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.
Flexible Work Arrangements:
Flex Time, Telecommuting
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