... and Merck and Life Science standards and procedure. Responsible for the analysis, development, and operation of quality and risk management systems. Activities include developing standards for ...
60 Merck Group Project Management Jobs Hiring Near You
... and Merck and Life Science standards and procedure. Responsible for the analysis, development, and operation of quality and risk management systems. Activities include developing standards for ...
... Merck and LS standards and procedures * Serve as a technical authority in drug regulations and ... Create, manage, and drive effective plans to improve the culture of quality with defined actions ...
... Merck and LS standards and procedures * Serve as a technical authority in drug regulations and ... Create, manage, and drive effective plans to improve the culture of quality with defined actions ...
... Merck and LS standards and procedures * Serve as a technical authority in drug regulations and ... Create, manage, and drive effective plans to improve the culture of quality with defined actions ...
... Merck and LS standards and procedures * Serve as a technical authority in drug regulations and ... Create, manage, and drive effective plans to improve the culture of quality with defined actions ...
Assoc Dir., Clinical Quality Mgmt. Lead
Billerica, MA · On-site
$122K - $202K/yr
... Merck KGaA, Darmstadt, Germany. Who You Are Minimum Qualifications: * Bachelor's/Master's in ... Strong project & change management skills, ability to work independently in fast-paced settings Pay ...
Assoc Dir., Clinical Quality Mgmt. Lead
Billerica, MA · On-site
$122K - $202K/yr
... Merck KGaA, Darmstadt, Germany. Who You Are Minimum Qualifications: * Bachelor's/Master's in ... Strong project & change management skills, ability to work independently in fast-paced settings Pay ...
Strategic Product Manager- Tangential flow filtration USA
Bedford, MA · On-site
$87K - $131K/yr
... management and next generation technologies for (bio-)pharmaceutical production acting as a ... Drive critical innovation projects: business case and concept briefs preparation, market assessment ...
Strategic Product Manager- Tangential flow filtration USA
Bedford, MA · On-site
$87K - $131K/yr
... management and next generation technologies for (bio-)pharmaceutical production acting as a ... Drive critical innovation projects: business case and concept briefs preparation, market assessment ...
Senior Engineer
Bedford, MA · On-site
$116K - $177K/yr
MilliporeSigma, a business of Merck KGaA, Darmstadt, Germany, is seeking a Sr. Engineer to join ... Manage project scope, timelines, budgets, and risk (e.g., FMEA); provide post-launch support and ...
Senior Engineer
Bedford, MA · On-site
$116K - $177K/yr
MilliporeSigma, a business of Merck KGaA, Darmstadt, Germany, is seeking a Sr. Engineer to join ... Manage project scope, timelines, budgets, and risk (e.g., FMEA); provide post-launch support and ...
Director, Global Labeling - Regulatory Affairs
Billerica, MA · On-site
$159K - $210K/yr
SpringWorks Therapeutics, a healthcare company of Merck KGaA, Darmstadt, Germany, is a commercial ... Prepare for senior management (LDB) review and approval. * Ensure all labeling is scientifically ...
Director, Global Labeling - Regulatory Affairs
Billerica, MA · On-site
$159K - $210K/yr
SpringWorks Therapeutics, a healthcare company of Merck KGaA, Darmstadt, Germany, is a commercial ... Prepare for senior management (LDB) review and approval. * Ensure all labeling is scientifically ...
Senior Project Manager
Jaffrey, NH · On-site
$116K - $185K/yr
Bachelor of Science Degree in Plastics Engineering, Biomedical Engineering, or other Engineering discipline and 5+ years of work experience in project management or injection molding production ...
Senior Project Manager
Jaffrey, NH · On-site
$116K - $185K/yr
Bachelor of Science Degree in Plastics Engineering, Biomedical Engineering, or other Engineering discipline and 5+ years of work experience in project management or injection molding production ...
Global HRBP and Head of US HR, Electronics
Allentown, PA · On-site
$177K - $266K/yr
... Merck KGaA, Darmstadt, Germany and member of the Electronics HR Leadership Team. * Lead the HR agenda for an organization of approximately 2,000 employees in the US and manage a team of 5 direct ...
Global HRBP and Head of US HR, Electronics
Allentown, PA · On-site
$177K - $266K/yr
... Merck KGaA, Darmstadt, Germany and member of the Electronics HR Leadership Team. * Lead the HR agenda for an organization of approximately 2,000 employees in the US and manage a team of 5 direct ...
ERP Senior Project Manager
Saint Louis, MO · On-site
$116K - $159K/yr
Project Planning and Management: Define project scope, goals, and deliverables that support business objectives in collaboration with senior management and stakeholders. Develop full-scale project ...
ERP Senior Project Manager
Saint Louis, MO · On-site
$116K - $159K/yr
Project Planning and Management: Define project scope, goals, and deliverables that support business objectives in collaboration with senior management and stakeholders. Develop full-scale project ...
Validation Project Managers
Burlington, MA · On-site
$78K - $98K/yr
... project management and scheduling tools such as SalesForce, Smartsheet, SharePoint, and Microsoft 360 gained through at least two years of work experience; 3) Demonstrated knowledge of quality ...
Validation Project Managers
Burlington, MA · On-site
$78K - $98K/yr
... project management and scheduling tools such as SalesForce, Smartsheet, SharePoint, and Microsoft 360 gained through at least two years of work experience; 3) Demonstrated knowledge of quality ...
ERP Senior Project Manager
Burlington, MA · On-site
$116K - $159K/yr
Project Planning and Management: Define project scope, goals, and deliverables that support business objectives in collaboration with senior management and stakeholders. Develop full-scale project ...
ERP Senior Project Manager
Burlington, MA · On-site
$116K - $159K/yr
Project Planning and Management: Define project scope, goals, and deliverables that support business objectives in collaboration with senior management and stakeholders. Develop full-scale project ...
Executive Coordinator (PMO)
Burlington, MA · On-site
$34 - $52/hr
The Executive Coordinator (PMO)provides high-level administrative support to two senior leaders while actively contributing to communications engagement and Project Management Office (PMO) operations.
Executive Coordinator (PMO)
Burlington, MA · On-site
$34 - $52/hr
The Executive Coordinator (PMO)provides high-level administrative support to two senior leaders while actively contributing to communications engagement and Project Management Office (PMO) operations.
Project Engineer
Sheboygan Falls, WI · On-site
$69K - $104K/yr
Manage and execute process improvement projects within stipulated timeframes and budget constraints, ensuring they meet intended design specifications as per the capability of Project Excellence.
Project Engineer
Sheboygan Falls, WI · On-site
$69K - $104K/yr
Manage and execute process improvement projects within stipulated timeframes and budget constraints, ensuring they meet intended design specifications as per the capability of Project Excellence.
Megasys Project Coordinator
Santa Clara, CA · On-site
$41 - $62/hr
MEGASYS ® offers specialized services in managing gases, chemicals and slurries, where our ... The Project Coordinator will handle daily project assignments and activities essential in ensuring ...
Megasys Project Coordinator
Santa Clara, CA · On-site
$41 - $62/hr
MEGASYS ® offers specialized services in managing gases, chemicals and slurries, where our ... The Project Coordinator will handle daily project assignments and activities essential in ensuring ...
Senior Project Engineer
Jaffrey, NH · On-site
$116K - $175K/yr
Manage change control and re-validation to maintain ongoing compliance. * Equipment build ... Project governance and planning * Develop and maintain WBS, schedules, milestones, and critical ...
Senior Project Engineer
Jaffrey, NH · On-site
$116K - $175K/yr
Manage change control and re-validation to maintain ongoing compliance. * Equipment build ... Project governance and planning * Develop and maintain WBS, schedules, milestones, and critical ...
Facilities Project Engineer
Sheboygan Falls, WI · On-site
$97K - $146K/yr
... projects are delivered on schedule, within budget, and with team accountability ... Develop and manage site utility infrastructure to ensure operations are reliable and robust for ...
Facilities Project Engineer
Sheboygan Falls, WI · On-site
$97K - $146K/yr
... projects are delivered on schedule, within budget, and with team accountability ... Develop and manage site utility infrastructure to ensure operations are reliable and robust for ...
Principal Project Engineer
Jaffrey, NH · On-site
$112K - $168K/yr
At the same time, you might have the opportunity to manage smaller projects from ideation to implementation. You will also contribute to the execution of the LS strategy and strive for technological ...
Principal Project Engineer
Jaffrey, NH · On-site
$112K - $168K/yr
At the same time, you might have the opportunity to manage smaller projects from ideation to implementation. You will also contribute to the execution of the LS strategy and strive for technological ...
Business Development Manager - Strategic Capital Projects (Process Solutions, Commercial Americas)
Burlington, MA · On-site
$107K - $179K/yr
... Management, GSA Directors, Franchise Teams and Operations Leaders. * Coordinate engagement across GSA account teams, project stakeholders, and Americas Process Solutions Regional commercial teams to ...
Business Development Manager - Strategic Capital Projects (Process Solutions, Commercial Americas)
Burlington, MA · On-site
$107K - $179K/yr
... Management, GSA Directors, Franchise Teams and Operations Leaders. * Coordinate engagement across GSA account teams, project stakeholders, and Americas Process Solutions Regional commercial teams to ...
Associate Director, Project Representative/Lab Manager
Billerica, MA · On-site
$164K - $246K/yr
You will be responsible for managing the overall DMPK contributions to specific NBE projects, including antibody oligonucleotide conjugates (AOCs) and other biologics, from molecule design through ...
Associate Director, Project Representative/Lab Manager
Billerica, MA · On-site
$164K - $246K/yr
You will be responsible for managing the overall DMPK contributions to specific NBE projects, including antibody oligonucleotide conjugates (AOCs) and other biologics, from molecule design through ...
Merck Group Jobs Information
What is it like to work at Merck Group?
What makes Merck Group an attractive place to work?

Full-time
Medical, Retirement, PTO
Posted 26 days ago
Job description
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Candidates can located in Rockville, MD or Glasgow, UK
Your Role:
A leadership role responsible for designing, implementing, maintaining, and improving the Quality Management System (QMS) to ensure compliance with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), applicable International Council for Harmonization (ICH) and International Organization for Standardization (ISO) guidelines/standards, other global regulatory requirements as outlined in the BioReliance Testing Services Global Quality Manual, and Merck and Life Science standards and procedure. Responsible for the analysis, development, and operation of quality and risk management systems. Activities include developing standards for quality, documentation, and processes as well as continuous improvement and preventive activities. Directs the resolution of highly complex or unusual operational problems applying advanced analytical thought.
- Lead the governance of core quality systems to ensure they are compliant with cGxP regulations, applicable ICH and ISO guidelines, and Merck and LS standards and procedures
- Drive continuous improvement of quality systems and harmonize procedures across global sites to enhance efficiency
- Leverage close collaboration across different geographies (US, EU, UK, APAC) and proactively seek support from key stakeholders to obtain the required input and alignment with Quality strategies
- Responsible for ensuring compliance to regulatory standards in the conduct and reporting of work performed
- Create, manage, and drive effective plans to improve the culture of quality with defined actions, timelines, and KPI reporting to BioReliance CTS leadership, Quality and site leadership, or other Merck stakeholders as required
- Ensure the review and approval of quality system records including deviations, investigations of Out of Specification (OOS) and anomalous results, CAPA, etc.
- Ensure the robust conduct of investigations to identify root causes and drive continuous improvement across the organization
- Collaborate, identify, and implement risk-based strategies to identify, assess, and mitigate QMS risks across the organization
- Participate in site readiness activities and provide Quality Systems support in managing client audits, internal audits, and regulatory inspections
- Advocate and drive standardization of quality approaches and procedures across the global quality framework where appropriate
- Participate in or lead other activities as required by Senior Management. This will involve participation in meetings across different time zones
Candidates can located in Rockville, MD or Glasgow, UK
Financial Dimension:
- Manage resource and financial planning to ensure alignment with business needs and quality requirements.
Management of People:
- Recruit, lead, train, and develop a high performing team to respond to business demands while ensuring compliance to quality and regulatory requirements
- Responsible for day-to-day management, setting objectives, coaching, developing employees, performance appraisal, and recommending employee compensation
- Provides leadership and direction through supervisors/managers
Who You Are
Minimum Qualifications:
- Bachelor's degree in a scientific discipline; advanced degree preferred
- Certification in Lean Six Sigma and a Quality related area is beneficial
- 10+ years working in a cGMP/GLP environment FDA/EMA or equivalent regulated industry such as pharmaceutical and biopharmaceutical, devices and diagnostics and a track record of quality improvement and execution
- 8+ years of leadership experience in Quality Assurance in Bio/Pharmaceutical or Life Sciences industry
- Strong relationship building and negotiation strategies, ability to influence, network, drive and manage change. Previous experience in a client facing Quality role is preferred
- Working knowledge of 21 CFR 11, 58, 210 & 211, EU GMP, MHRA GLP & GMP, OECD GLP, ICH Q7, ISO 9001, and other applicable regulations, standards, and guidelines
- Expertise in managing and leading the transformation of quality systems such as investigations of nonconformances including deviations and out of specification investigations, corrective actions and preventive actions (CAPA), effectiveness checks, management control, internal audits, and change controls
- Experience with regulated products or services across different geographies preferred
- Mastery in hosting regulatory inspections and managing responses
Preferred Qualifications:
- Fluent in both written and spoken English
- Excellent leadership & management skills
- Excellent communication, interpersonal & conflict resolution skills
- Excellent working knowledge of implementing, managing & applying QMS in a US/EU/APAC GxP environment
- Leadership experience in building and/or enhancing quality systems such as investigations, change controls, etc.
- Direct experience in communicating with regulatory authorities preferred
- Leadership skills in managing change, attracting/developing talent, and coupling high performance standards with soft skills
- Experience of managing a global operation preferred
Pay Range for this position: $154,700-$290,300
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!