Merck Associate Director, Quality Systems & Compliance in Helena, Montana
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.
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 interlinking global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
We are seeking a Growth and Improvement minded Quality Systems & Compliance Associate Director that can help drive our Strategic Operating Priorities.
Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
Diverse Talent | We are dedicated to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us
Implementation of key quality systems in the Large Molecule External Manufacturing Drug Product Platform
Oversight and management of complaints for all externally manufactured Large Molecule products | Coordinates with the external partner and other internal/external sites to investigate the complaint and drive appropriate root cause and CAPAs | Conducts trending for complaints and interfaces with global Complaints Center of Excellence and Lines of Business to identify and address trends
Quality Council process, collecting and analyzing data, and preparing and presenting content to Leadership Teams | Partners with SMEs to identify and coordinate topics of interest for the meetings | Interfaces with various Leadership teams as part of the Quality Council Coordinator role
Health Authoring Reporting for all of Large Molecule | Assesses events such as complaints and deviations and determines the need to report the event | Works with responsible teams to author and submit the required health authority notification and any follow-up actions
Facilitates the implementations of assessments (e.g. Company Sterile Standards, Quality Risk Assessments, Data Integrity) for our external partner including the management of updates to the Quality Management System assuring that the external partners adhere to regulatory guidance
Ensures permanent audit readiness, regulatory inspection support and monitoring, effective complaint management, change control oversight, metric review, and review of annual product reviews. This also includes providing support to build effective quality systems at the EE and supporting continuous improvement activities.
Serves as EQA and Manufacturing Division subject matter expert in specific Quality systems, technology platforms, regulatory expectations and/or EE management | Utilizes this expertise to drive improved and compliant processes/systems for EQA and the company Manufacturing Division
In addition to supporting the quality operations activities at the External Entity, will support the execution of Strategic Initiatives related to compliant supply, operationalizing quality and developing an engaged and capable workforce
Support External Entities located in the US and Europe
- Bachelor degree in Science, Engineering or other relevant technical discipline
Work independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
Eight years in a pharmaceutical GMP manufacturing setting with thorough knowledge of Quality Systems, Quality Assurance and Quality Control including global GMP Quality Systems and regulatory requirements
Aseptic manufacturing experience, experience with regulatory inspections and knowledge of multi-national regulatory agency cGMP expectations
Principled verbal and written communications
Effective interpersonal, communication, coaching, motivation, negotiation, and persuasion skills to build strong relationships
Manufacturing operations and/or analytical expertise associated with biologics and/or vaccines
Direct experience with managing external partners
Quality Risk Management (QRM) e.g. Risk Lead, Facilitator
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.
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 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 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.
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Flexible Work Arrangements:
1st - Day
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Number of Openings:
Requisition ID: R181256