Senior Manager, Quality Management Lead

2 weeks ago

Bernards, United States Regeneron Pharmaceuticals, Inc Full time

The Senior Manager, Global Development Quality Management (GCP) acting as a Quality Management Lead (QML) is a key position that will provide mentorship and leadership for all aspects of quality and compliance. The incumbent will engage with key collaborators, build strategic partnerships working and collaborating closely with study teams, relevant functions and other GDQ functions. Lead risk-based quality activities on all Regeneron-sponsored clinical trials, inclusive of issue management and providing continuous support of inspection readiness.

A day in the life may look like:

Subject Matter Authority (SME) and key liaison to GDQ to provide support and advise on any issues to ensure compliance and for the Quality Risk Assessment process. Ensuring and responsible for initiatives and process improvements, in partnership with other functional areas. Responsible for the management of GCP-compliant activities from a quality perspective in conjunction with the business and the GDQM (GCP) team. Providing day-to-day quality and compliance support to cross-functional collaborators. Including issue management (triage/investigation/actions), audit responses, proactive quality management, Corrective Action/Preventive Action (CAPA) oversight

This may be the right role for you if you have experience:

Leading Quality Risk Management activities on clinical trials within assigned studies and Control Tracker (QRACT) activities at the time of Protocol development predicated on ICH E6 R2. Partnering with Clinical Study Lead/Oversight Monitoring and CRO to provide oversight to site level quality risks. Working together with other GDQM (GCP) QMLs in relation to effective management of study specific issues. Responsible for owning the critical issue, to Executive Quality Leadership, for significant quality events and quality trends relative to studies, programs, and therapeutic areas. Advising on the escalation of any quality issues that potentially represent serious non-compliances (or serious breach)

In order to be considered for this role, we are looking for candidates who have:

Bachelor's degree or equivalent experience with a minimum of 8 years of relevant healthcare/pharmaceutical proven experience in either a quality/compliance role or in a Clinical Development role. Strong Expertise with transferable skills related to Good Clinical Practice(GCP), and/or Good Pharmacovigilance Practice (GVP).

  • Sr. Manager, Project Manager

    4 days ago

    Bernards, United States ProClinical Full time

    Proclinical is seeking a dedicated and dynamic individual for the role of Contractor, Global Development Project Management. This role involves providing project management, project implementation, and change management support for non-drug/study projects. The successful candidate will work closely with senior leaders and project teams, leading projects to...

  • Financial Planning and Analysis Manager

    1 month ago

    Bernards, United States Spectrum Staffing ServicesHRStaffers Inc. Full time

    SUMMARYThis position is responsible for the quarterly global consolidation, supporting both external reporting and internal management financial reporting for a collaboration program. This position has responsibilities of working closely with various functions within the company and acting as a liaison with the external partner for a smooth consolidation...

  • Product Manager

    3 weeks ago

    Bernards, United States Lawyer.com Full time

    Lawyer.com is looking for a Junior Product Manager to assist our VP of Product Development.Your main responsibility will be to become the company expert on our Premium Membership, the flagship service of Lawyer.com. Your knowledge and efforts will improve the overall Member Experience, therefore increasing sales and improving Member retention.Above all, your...

  • Director, Regulatory Affairs Strategy, Hematology

    3 weeks ago

    Bernards, United States Regeneron Pharmaceuticals, Inc Full time

    The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include support to some clinical study activities. The...

  • GHIN Internship

    1 month ago

    Bernards, United States teamworkonline Full time

    The USGA is a mission-based golf organization whose purpose is to unify the golf community through handicapping and grassroots programs; to showcase the game’s best talent through the U.S. Open, U.S. Women’s Open and 13 other national championships and our museum; to provide unbiased global governance with The R&A through the playing, equipment and...

  • Associate Director, Clinical Scientist, Hematology

    3 weeks ago

    Bernards, United States Regeneron Pharmaceuticals, Inc Full time

    The Associate Director, Clinical Scientist leads in the development, evaluation, planning and execution of hematology oncology clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. Leads in a matrix environment as part of a cross-functional team and may contribute to candidate development...

  • Associate Director, Biostatistics

    6 days ago

    Bernards, United States Joulé Full time

    Job Title: Associate Director, Biostatistics Client - Global Pharmaceutical Company Location: Remote, US Based only - must reside in EST or CST time zones Type: Direct Hire - Full time salaried direct with the client Base Salary: $180k - $195K Must Haves: Oncology lead experience. PhD 5+ years Oncology clinical trial experience OR Master in...

  • Chief Financial Officer

    1 day ago

    Bernards, United States Clark Davis Associates Full time

    My client is a privately held commercial Real Estate investment and development firm focused on deep value creation for their investors and partners. The company is highly respected for their innovative re-positioning and development of multiple asset types.They are seeking a strategic, operational, and process-oriented CFO who will work closely with the CEO...

  • Human Resources Administrator

    4 weeks ago

    Bernards, United States Collabera Full time

    Basic PurposeAssist Human Resources department in ensuring fair treatment and protect the rights of all employees per state and federal labor laws. Help the Company comply with state and federal regulations by following best practices. Assist in implementation of Collabera’s cultural values. Essential Duties and Responsibilities Assist HR Manager in all...

  • Linux Systems Administrator

    1 week ago

    Bernards, United States Procession Systems Full time

    Job Description2862 - Linux Engineer, Required SkillsREQUIRED QUALIFICATIONS:8 years of experience in application prototype development and a Bachelor's Degree from an accredited college or university in Computer Science, Information Technology, or a related discipline. Master's degree with 6-8 years of experience, or PhD 3-5 years of experienceIn lieu of a...

  • Product Designer

    3 weeks ago

    Bernards, United States Insight Global Full time

    Duration: End of Year + ExtensionLocation: Hybrid - Basking Ridge, NJMust-haves 4+ years of experience as a Product Designer in enterprise environmentsHands on with end to end UX/UI design for consumer products, platforms or servicesStrong documentation with full UX design process; user research, usability testing, flow charts, journey mapping, prototypes,...

  • Therapy Assistant

    3 weeks ago

    Bernards, United States Veterans Health Administration Full time

    Summary These positions are located within the Physical Medicine & Rehabilitation (PMR) Service, Recreational Therapy Section at the VA New Jersey Health Care System (VANJHCS) at the Lyons, NJ campus. The Therapy Assistant works with Veterans who have a variety of illnesses, diseases, and/or disabling conditions with varying degrees of impairment. ...

  • GHIN Internship

    1 month ago

    Township of Bernards, New Jersey, United States teamworkonline Full time

    The USGA is a mission-based golf organization whose purpose is to unify the golf community through handicapping and grassroots programs; to showcase the game's best talent through the U.S. Open, U.S. Women's Open and 13 other national championships and our museum; to provide unbiased global governance with The R&A through the playing, equipment and Amateur...

  • Paid Media Internship

    3 weeks ago

    Township of Bernards, New Jersey, United States teamworkonline Full time

    The USGA is a mission-based golf organization whose purpose is to unify the golf community through handicapping and grassroots programs; to showcase the game's best talent through the U.S. Open, U.S. Women's Open and 13 other national championships and our museum; to provide unbiased global governance with The R&A through the playing, equipment and Amateur...

  • Field Engineer 2

    1 week ago

    Bernards Twp, United States ThreePDS Inc. Full time

    NEEDED!!! A/V Technician in Basking Ridge, NJJob Details: Job Class: FE 2 A/V Tech Work Location: Basking Ridge, New Jersey 07920 Driving/Non-Driving: Non-Driving Duration: 10-12 month contract with possibility conversion to perm for right candidate Minimum Experience: 3 years and must be reflected on resume Pay Range: $25-28/hr based on experience Skillset...

  • REGISTERED NURSE OPERATING ROOM, PART TIME

    3 weeks ago

    Basking Ridge, Bernards, NJ 07920, USA, United States Surgery Care Affiliates Full time

    OverviewToday, SCA Health has grown to 11,000 teammates who care for 1 million patients each year and support physician specialists holistically in many aspects of patient care. Together, our teammates create value in specialty care by aligning physicians, health plans and health systems around a common goal: delivering on the quadruple aim of high-quality...

  • RN OPERATING ROOM

    3 weeks ago

    Basking Ridge, Bernards, NJ 07920, USA, United States Surgery Care Affiliates Full time

    OverviewToday, SCA Health has grown to 11,000 teammates who care for 1 million patients each year and support physician specialists holistically in many aspects of patient care. Together, our teammates create value in specialty care by aligning physicians, health plans and health systems around a common goal: delivering on the quadruple aim of high-quality...

  • RN OPERATING ROOM

    3 weeks ago

    Basking Ridge, Bernards, NJ 07920, USA, United States Surgical Care Affiliates, LLC Full time

    Overview Today, SCA Health has grown to 11,000 teammates who care for 1 million patients each year and support physician specialists holistically in many aspects of patient care. Together, our teammates create value in specialty care by aligning physicians, health plans and health systems around a common goal: delivering on the quadruple aim of high-quality...

  • REGISTERED NURSE OPERATING ROOM, PART TIME

    3 weeks ago

    Basking Ridge, Bernards, NJ 07920, USA, United States Surgical Care Affiliates, LLC Full time

    Overview Today, SCA Health has grown to 11,000 teammates who care for 1 million patients each year and support physician specialists holistically in many aspects of patient care. Together, our teammates create value in specialty care by aligning physicians, health plans and health systems around a common goal: delivering on the quadruple aim of high-quality...