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 interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
Basic Functions and Responsibilities:
Distribution & Logistics (D&L) Quality Lead - Individual contributor responsible for ensuring that all our Company products managed by our Company through own sites and External Partners are manufactured, packaged, analyzed, released, stored, and distributed in accordance with our Company expectations and all applicable regulatory requirements. Individual serves the leadership role for: 1) the management and collaboration with Supply Chain Management for the oversight of External Partners/ Parties responsible for the distribution of our Company finished products and / or 2) the management and collaboration with Packaging Technology for the oversight of External Thermal/ Distribution Testing Labs.
Primary Responsibility will include:
- Liaison with Shipping sites to oversees Shipments
- Support sites with TOR/TOCs for shipping process
- Management of External Partners/ Parties/ Testing Labs
- Creation/ Maintenance of Quality Agreements
- Establishment and Monitoring of Quality Metrics
- Day to Day Operational Support (i.e. deviations; change control; SAP transactions; review of testing protocols/ reports; etc.).
- Support of Significant Investigations and possible Regulatory Notifications
- Escalation of Risks to Senior Management
- As required on-site support at the External Partners/ Parties/ Testing Labs
- Participation in cross-functional continuous improvement initiatives
Primary Activities include, but are not limited to the following:
- Serve as Quality Liaison between the External Partners/ Parties/ Testing Labs and our Company.
- Assure that the External Partners/ Parties/ Testing Labs operate within established policies and procedures and complies with all applicable governmental regulations (GMP, GDP, etc.).
- Assist with and/or lead the development, and ongoing execution of the Quality Agreement with the External Partners/ Parties/ Testing Labs and act as the Quality expert on our Company behalf regarding contractual negotiations
- Leverage measures/metrics to provide on-going supplier performance management (KPI, trend analysis, etc.)
- Manage compliance issues promptly and perform risk assessments on critical issues to prevent disruptions to supply (i.e. stock out situation) of the market
- Maintain regular onsite presence to build relationships and provide first hand oversight and/or performance monitoring; based on risk
- Ensure that all deviations at the External Partners/ Parties/ Testing Labs related to our Company Products are fully investigated; with any assigned actions effectively implemented within the agreed time frame
- Provide direct oversight to strategic/complex deviations and/or complaints; lead significant investigations (including Fact Findings) and coordinate product recalls as needed
- Conduct Tier meetings and Business Review Meetings to achieve our Company Manufacturing and objectives
- Bachelors Degree in Science, Engineering or other relevant technical discipline (e.g. BS/MS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent preferred)
- At least 5 years experience in the Pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance including solid knowledge of global GMP/ GDP (Good Distribution Practices) Requirements
- Possess a combination of analytical/scientific skills in order to effectively manage and control all activities necessary to support a Quality Operations program governing external parties/partners that store and distribute our Company product.
- Broad knowledge of Distribution, External Supplier management, supply chain, Quality Assurance
- Competent in analyzing complex product, distribution, and transportation issues, and have demonstrated scientific problem solving capabilities
- Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills
- Works independently, with guidance in only the most complex situations
- Acts as a resource for colleagues across multiple areas
- Solves complex problems; takes a broad perspective to identify innovative solutions
- Manages large or multiple small projects with moderate resource requirements, risk and/or complexity
- Anticipates internal/external business and regulatory/compliance issues; recommends product, process or service improvements
- Communicates easily in English both verbally and in writing
- Ability to make decisions in an ambiguous environment
- Lean Six Sigma / our Company Product ion Systems training
- Ability to travel 20% of the 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 .
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 firstname.lastname@example.org
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster at https://www1.eeoc.gov/employers/upload/eeocselfprint_poster.pdf
EEOC GINA Supplement at https://www1.eeoc.gov/employers/upload/eeocginasupplement.pdf
OFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
OFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdf
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