- Merck & Co. (Durham, NC)
- Job DescriptionThe Quality Associate Director/GMP Lead Site Auditor will have leadership responsibility for the site internal audit program, encompassing the ... Function as a change agent related to culture and audit program performance Lead change and process improvement initiatives related to Auditing, Inspections,… more
- Merck & Co. (Rahway, NJ)
- …ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The ... and finalization, and feed to the Submissions Assembly team. The Business Operations Lead should be able to understand the various source area processes and apply… more
- Eisai, Inc (San Francisco, CA)
- …translational and clinical goals. At the same time, they will ensure data quality , harmonization across teams, and continuous process improvement , making a ... across its development portfolio. This role offers the opportunity to lead high-impact imaging strategies-from trial design and execution to data… more
- Merck & Co. (Rahway, NJ)
- …medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- ... products and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead … more
- Merck & Co. (Rahway, NJ)
- …with regulatory, company, and customer requirements. - Principal Responsibilities Lead /Support continuous improvement initiatives for design control and ... Required Experience and Skills: 10+ years of experience in process improvement , Quality management system, operational excellence, and product development… more
- Merck & Co. (Rahway, NJ)
- …(CSO), Logistics and Regions, and External Partnerships & Supply (EPS).- The technical lead owns business continuity of GCS facilities and equipment as well as ... day-to-day support of technical equipment-based challenges when required.- The technical lead may also manage global infrastructure projects to establish, upgrade,… more
- Merck & Co. (Rahway, NJ)
- …Maintenance protocols, Calibration procedures, Training, and SOPs for all GxP automation systems. Lead integration of control systems with MES, Quality , and Batch ... our state of the facility and actively contribute to continuous improvement projects. Job Responsibilities: Provide key automation support for various manufacturing… more
- Merck & Co. (Rahway, NJ)
- …strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Center of Excellence ... support to life cycle changes, investigations, trouble shooting and continuous improvement initiatives to guarantee the robustness and compliance of our company's… more
- Aequor (Thousand Oaks, CA)
- Remote - local to ATO to come onsite as needed preferrable Key Responsibilities: Agile Delivery & Project Leadership Lead Agile ceremonies (planning, reviews, ... and ensure teams operate with strong discipline, transparency, and continuous improvement . Build and maintain detailed project plans, sprint schedules, work… more
- Syner-G BioPharma Group (Boston, MA)
- …bring life-saving innovations to market faster, at scale, and with the highest quality . Our team partners with a diverse range of clients across the life ... provide strategic guidance and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance, empowering our clients to… more
- Insmed Incorporated (NJ)
- …and FDA data protection standards.Partner with Legal, Compliance, Clinical Operations, Quality and R&D to proactively manage risk across Insmed's technology ... role in protecting Insmed's mission and assets. Hands-On Technical Leadership Lead and participate directly in cybersecurity operations , including incident… more
- Insmed Incorporated (NJ)
- …Under the guidance of the Associate Director, you will ensure high- quality , timely, and compliant preparation and delivery of regulatory documentation throughout ... reports) in alignment with established timelines, regulatory requirements, and internal quality standards Author and oversee the preparation of regulatory documents… more
- Cipla (Fall River, MA)
- …disability (LTD), parental leave, employee discounts, and other benefits. Work Hours/ Shift/ Remote General Shift: 15:00 - 23:30 (may vary based on business needs) ... Monitor packaging processes for adherence to cGMP, FDA, and Cipla's quality standards. Identify and resolve operational inefficiencies, escalating complex issues… more
- Merck & Co. (Rahway, NJ)
- …strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Logistics and Distribution ... analysis of inputs, outcomes, risks, and company-wide prioritization. Essential Responsibilities: Lead , mentor, and develop a team of technical staff, fostering a… more
- Insmed Incorporated (NJ)
- …analyze operational performance data to identify trends and opportunities for continuous improvement .Oversee quality control and audit readiness, serving as a ... MRC activities, compliance with company policies and regulatory standards, and the quality and integrity of all reviewed materials. By driving process excellence,… more
- Merck & Co. (Rahway, NJ)
- …modalities. We are interdependent across our functional areas, Discovery, our Manufacturing Division Quality , and BARDS, to name a few, and with our partners in ... seasoned Project Manager with a strong background in the biotech industry to lead digital transformation initiatives. This role will focus on helping the team build… more
- Syner-G BioPharma Group (Boston, MA)
- …bring life-saving innovations to market faster, at scale, and with the highest quality . Our team partners with a diverse range of clients across the life ... provide strategic guidance and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance, empowering our clients to… more
- Eisai, Inc (Philadelphia, PA)
- …as the primary liaison between R&D functions, acting as the submission lead for designated global applications (eg, INDs, NDAs, MAAs, supplements, amendments, and ... the operational aspects of global regulatory submissions to produce high- quality , time-sensitive deliverables in accordance with agreed-upon submission timelines.… more
- Merck & Co. (Rahway, NJ)
- …Biologics- Materials and Biophysical Characterization. The successful candidate will lead our biophysical characterization group in biologics, overseeing the ... properties of biopharmaceuticals. This role is critical to ensuring the quality , efficacy, and safety of our products through advanced biophysical techniques… more
- Merck & Co. (Rahway, NJ)
- …and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team.The Associate Director will lead ... on the analysis of inputs, outcomes, risks, and company-wide prioritization.Essential Responsibilities: Lead , mentor, and develop a team of technical staff, fostering… more
