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Associate Director Study Quality Operations Jobs

Awm Operations Quality Associate I
By JPMorgan Chase & Co At , Newark, 19713 $82,650 - $120,000 a year
Wealth management experience a plus
Create and simulate business process management diagrams in Signavio
Use Decision Model and Notation to support decision management and business rules applied in digital products
Excellent communication skills ensuring transparency across all stakeholders
Experience applying design, product, and project thinking throughout the product development lifecycle
Experience with Business Process and Decision Modeling
Director Quality Operations (Archived)
By GXPeople At ,
The salary banding provided is for guidance only and is dependent on experience.
If this is the case, please click on the apply button for further information.
This role is open to US and Canadian citizens only (or US Green Card holders).
Associate Director, Quality Operations
By BAXTER At , Marion $128,000 - $252,000 a year
Expert knowledge of regulations, and experience with interpretation and application
Provide direct supervision of individuals including mentoring, performance management and staffing decisions. Ability to lead/supervise a large team of employees
May participate in management of budgets
Excellent written and verbal communication, presentation, and facilitation skills· Strong negotiation skills and significant experience in interacting with regulatory authorities
Expert knowledge of FDA and other regulatory requirements (e.g. Eudralex, PICs, WHO) for pharmaceutical manufacturing
Implement policies to ensure ongoing compliance of regulatory requirements
Associate Director, Quality Operations
By MorphoSys At , Boston, Ma
Experience with electronic Quality Management Systems (eQMS) is desirable
10+ years of experience in the pharmaceutical, Biologics or health industry with demonstrated knowledge or experience in GMP Compliance
Strong knowledge in international regulations and guidelines (EU / FDA regulations, ICH etc.)
Work collaboratively in multi-functional teams as a key player with strong interpersonal and communication skills
Excellent organizational, communication, and interpersonal skills
Excellent documentation skills, e.g., reports, presentations, etc.
Qa Associate, Quality Operations
By Evotec At , Seattle, Wa
Possess effective task/time management organization skills.
Escalate to QA Operations management of any potential deviations, compliance risks.
Minimum of 2 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment preferably in QA Operations.
Prefers candidate with QA Operations experience with On-The-Floor oversight
Excellent verbal and written communication skills.
Previous experience working in Quality Assurance, Quality Control, or Drug Substance or Drug Product manufacturing
Global Study Management Associate
By BeiGene At , Remote $61,500 - $86,500 a year
Establishes good collaboration with Global Clinical Study Manager, Regional Clinical Trial Management Associates and other key stakeholders globally and regionally
Builds solid knowledge of global clinical trials operations under guidance of the Global Clinical Study Manager
Prepares metrics and updates to key deliverables for management as per information available in relevant systems
Supports management of global study budget incl PO set-up
Project Management - Communicates changes and progress; Completes projects on time and within budget.
Supports the alignment of study goals with clinical operations goals and objectives under direction of the Global Clinical Study Manager
Director Quality Operations Jobs
By Bioventus At Memphis metropolitan area, MS, United States
Strong computer skills including database or IT validation experience.
Manages development/implementation of quality control training programs for quality function.
Manages review of engineering and/or regulatory changes to assess their impact on quality systems and address deficiencies.
Ensures Company’s processes, procedures, specifications, policies and records continuously comply with Federal, international and other external regulations and requirements.
Manages internal and external audits and Inspections as needed.
Works with multiple project schedules and manages competing priorities
Associate Director, Operations Jobs
By PM Group At San Francisco, CA, United States

RECRUITMENT AGENCIES NEED NOT APPLY

Associate Director Clinical Study Management
By BeiGene At United States
Management experience of CROs, Vendors and Consultants preferred
Ensures the competencies and skills required for the Clinical team is consistent with the company defined requirements
Mentor junior team members to support development by delegating responsibilities, overseeing and supporting development plans
8+ years progressive experience in clinical operations preferably within the biotech, pharmaceutical, and/or CRO environment
Possess understanding of treatment landscape, standard of care, upcoming approvals, and good knowledge of KOLs and investigators
Experience developing trial plans including site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets and site selection/feasibility as required
Study Director Jobs
By Eurofins Lancaster Laboratories At South Brunswick, NJ, United States
Responsibilities as stated in GLP regulations.
Hands-on working knowledge of the tests that will be under their responsibility.
Good administrative skills and leadership ability. Must communicate effectively and write well.
Assist in protocol development, design and implementation.
Data interpretation and report writing.
Overall, day-to-day laboratory operation including supervision of technical staff assigned to your studies.
Program Manager, Study Operations
By Verily At Raleigh, NC, United States
Experience in study project management and prior management of contracted resources/CROs.
8+ years of clinical study management experience in registries, observational research, RWD/E, or clinical trials as a clinical study lead/project manager.
Deep knowledge of the range of tools used in the clinical study management space and associated technology solutions.
Identify and mitigate risks and apply strong problem-solving skills to ensure timely resolution of all project-related issues.
BA/BS/BScN degree in health or biologic science, or equivalent practical experience.
Master's degree in health or biologic science, or equivalent practical experience.
Program Manager, Study Operations
By Verily At Dallas, TX, United States
Experience in study project management and prior management of contracted resources/CROs.
8+ years of clinical study management experience in registries, observational research, RWD/E, or clinical trials as a clinical study lead/project manager.
Deep knowledge of the range of tools used in the clinical study management space and associated technology solutions.
Identify and mitigate risks and apply strong problem-solving skills to ensure timely resolution of all project-related issues.
BA/BS/BScN degree in health or biologic science, or equivalent practical experience.
Master's degree in health or biologic science, or equivalent practical experience.
Associate Director - Study Abroad
By University of Central Florida At Greater Orlando, United States
Strong written and oral communication skills are key to this position.
Experience with Terra Dotta, Workday, and PeopleSoft is desirable.
Benefit packages, including Medical, Dental, Vision, Life Insurance, Flexible Spending, and Employee Assistance Program
And more…For more benefits information, to go to the UCF Employee Benefits page click here.
Are Benefits Important to You?
Supervises personnel, as assigned. Supervises grant-funded Peace Corps Strategic Recruiter.
Associate Study Director - Fully Remote!!
By The Jackson Laboratory At Bar Harbor, ME, United States
Excellent management/supervisory project management and project oversight skills and proven experience with mentoring direct reports.
Knowledge and experience in using process improvement techniques and approaches such as lean six sigma preferred.
Excellent oral and written communication skills.
Demonstrated ability to develop and lead technical teams.
Quality Operations Director Jobs
By Olympus Corporation of the Americas At , Center Valley, 18034, Pa
Strong Quality Engineering background and experience – ASQ-CQE current certification desired.
Provides leadership, direction, and development for multiple levels of managers across the Quality Operations function
A minimum of 10 years experience in a technical/leadership role in medical device/regulated industry.
Previous people leadership experience required and experience leading the development and technical growth of colleagues to support business transformation.
Strong knowledge of quality, validation and manufacturing operations, specific to medical devices.
Knowledge of Integrated Manufacturing Excellence (IMEx) or other lean manufacturing approaches.
Associate Director Study Quality Operations
By Green Key Resources At Greater Boston, United States
Drive continuous improvement and knowledge management by sharing case studies/lessons learned from QA activities to minimize recurrence of similar issues
Significant experience with GxP investigations, risk assessments and CAPA management
Experience with multinational products and regulations as well as with mandated risk management plans
Where applicable provide appropriate quality metrics for established Quality Management Reviews (Global Quality, R&D etc.).
Participate in quality management reviews, risk reviews, and other study/TA/Asset level quality reviews to drive Clinical development and Operations Quality deliverables
Established knowledge of GxP/GCP regulations and guidelines (EMA, FDA, PMDA etc.)