Top 90 analytical validation manager Jobs in durham, nc

Principal Investigator
Guerbet —Raleigh, NC
- Full-time
- Bachelor of Science
- Microsoft Office
- 8 years
Business Intelligence III (Construction Ops)
McGough Construction —Raleigh, NC
- Hybrid work
- Azure
- Office
- 8 years
7d
HR Operations Analyst (Payroll & Compensation)
Kymera International - SCM Corp —Durham, NC
- Full-time
- Remote
- Mid-level
- 3 years
- Analysis skills
Quick Apply
Senior Manager, HR Technology (Workday PATT)
Labcorp —Durham, NC
- $140,000 - $170,000 a year
- Full-time
- Hybrid work
- Oracle
- Research
- Bachelor's degree
- Employee stock purchase plan
- Disability insurance
IRT Project Coordinator / Associate Project Manager eCOA Technologies
IQVIA —Durham, NC
- $57,000 - $142,700 a year
- Full-time
- Mid-level
- Analysis skills
- Bachelor's degree
4d
Senior/Commercial Pricing and Contracting Manager, Market Access
United Therapeutics —Research Triangle Park, NC
- $121,000 - $190,000 a year
- Full-time
- Remote
- Microsoft Word
- Microsoft Excel
- 6 years
- Paid parental leave
- Employee stock purchase plan
Senior Manager Data Systems- EHS
Cornerstone Building Brands —Cary, NC
- $125,000 - $145,000 a year
- Online Application
- Remote
- 18 years or older
- Computer Science
- System design
- Paid holidays
- Disability insurance
Quick Apply
HR Manager
Opal Hotels Group —Raleigh, NC
- $80,000 - $90,000 a year
- Full-time
- OSHA
- Customer service
- Hotel
Quick Apply
Director, Global Resilience and Physical Security
IQVIA —Durham, NC
- $112,200 - $312,700 a year
- Full-time
- 7 years
- Analysis skills
- Bachelor's degree
Quality Engineer 2, Quality Operations - Clinical Laboratory # 4790
GRAIL —Durham, NC
- $82,000 - $102,000 a year
- Overtime
- Hybrid work
- Bachelor of Science
- Mid-level
- Doctor of Philosophy
- Health insurance
- Dental insurance
Quick Apply
Sr. Director, R&D Chemistry
bioMérieux —Durham, NC
- $180,000 - $232,000 a year
- Microsoft Outlook
- 5 years
- Bachelor's degree
- Commuter assistance
- Disability insurance
Quick Apply
Category Manager, Clinical Contracts
Owens & Minor Distribution Inc. —Raleigh, NC
- $100,000 - $130,000 a year
- Full-time
- Hybrid work
- 7 years
- Finance
- Analysis skills
- Health savings account
- Disability insurance
Quick Apply
Patient Account Team Lead - DUH ED
Duke University —Durham, NC
- Microsoft Word
- 5 years
- Mid-level
Metrologist
MedPharm —Durham, NC
- Full-time
- Bachelor of Science
- Mid-level
- Associate's degree
Quick Apply
Marketing Engagement Associate Manager
Accenture —Raleigh, NC
- $73,800 - $182,600 a year
- Full-time
- Remote
- Marketing
- Writing skills
- Analysis skills
- Paid holidays
- Disability insurance
Manager, Payroll N.A.
Wasserman Media Group LLC —Raleigh, NC
- $110,000 - $125,000 a year
- Full-time
- 5 years
- Finance
- Analysis skills
- Commuter assistance
- Paid parental leave
Business Development Associate - Pharmaceutical
Ecolab Inc. —Raleigh, NC
- $93,800 - $140,600 a year
- Overtime
- Research
- Mid-level
- Bachelor's degree
- Opportunities for advancement
External Manufacturing Senior Manager (DS/DP)
Sobi —Raleigh, NC
- $130,000 - $165,000 a year
- Full-time
- Hybrid work
- 5 years
- English
- Computer skills
- Health insurance
- Dental insurance
Quick Apply
Laboratory Supervisor - Central Automated Lab - Third Shift
Duke Health —Durham, NC
- Full-time
- Hospital
- 5 years
- Bachelor's degree
BCG Platinion | Manager, Enterprise Solutions – Advanced Planning Systems – Kinaxis
Boston Consulting Group —Durham, NC
- $190,000 a year
- Full-time
- 5 years
- Urgent Care
- Master's degree
- Paid parental leave
- Paid holidays

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analytical validation manager jobs near durham, nc

Principal Investigator

Guerbet -
Raleigh, NC

Apply Now

Job Details

Full-time

Qualifications

Corrective and preventive actions (CAPA)
Pharmaceutical company experience
Pharmaceutical manufacturing facility experience

Full Job Description

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients.

Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging.

WHAT WE ARE LOOKING FOR

This position is an active principal level position within the QA Compliance department. The position may have direct reports and is required to work cross functionally throughout the plant to ensure compliance levels are maintained and that results are obtained from indirect reports. This person is expected to be a SME (Subject Matter Expert) for site compliance related functions including Exceptions, CAPAs, Complaints, Remediation Enhancements, and Trending.

YOUR ROLE

Primary duties include:

Lead position in the site execution of external audits from regulatory agencies (i.e SME, Inspection Room Representative). Position will take a lead role in the formulation of inspection responses and commitment completion follow-up.
Assist in the department completion of trending and metrics (i.e Cost of Poor Quality, Key Performance Indicators, Quality Management Reviews, & Data Trend Analysis)
Complete department requirements for site Annual Product Quality Reviews (APQRs). Must have the ability to assess shifts and trends, as well as associate CAPA response as it relates to data obtained.
Ability to write, review and final approve site related complaints, exceptions, and CAPA RCA investigations within a timely manner. When needed, may also perform investigations within each of the compliance quality systems.
Possess process technical knowledge and writing capabilities.
Ability to lead site Kaizens or brainstorming initiatives.
Ability to support site annual or non-routine GMP training.
Primary designee for Quality Operations Manager in his/her absence.
Proactively manage and maintain regulatory compliance (US/EU/WHO/Brazilian/Korean standards).
Providing day to day supervision and oversight of Operations QEs.
Performs other duties as assigned by management.

Department Specific/Non-Essential Functions:

Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately.
Support various information requests from Corporate and other departments. Interact with corporate support groups to drive global continuous improvement validation and supplier management programs.
Assist QA Compliance Manager with special assignments or projects as directed.
Seek out and apply best quality assurance methods and practices in support of Quality objectives.
Performs other duties as assigned by management.

YOUR BACKGROUND

Education required/ preferred: Minimum BS/BA degree in Life Sciences or Business. MS preferred.
Experience: Minimum 8-12 years’ experience in a pharmaceutical setting.
Preferred Skills/Qualifications: ASQ certified inspector/auditor preferred.
Analytical knowledge of Microbiology and Chemistry is preferred.
Good documentation skills with eye for details and ability to identify hidden problems within processes and systems.
Skills/Competencies: Ability to work in a fast-paced environment; Proficient in multi-tasking; Well organized and reliable for consistent decision making
Other Skills: Strong Technical Writing Skills; Competent with MS Office software environment; Ability to interact with all levels of the organization.

Physical Requirements:

May be required to sit or stand for extended periods of time.
May have extended exposure to computer screens.

Cognitive Requirements:

The position routinely interfaces with various personnel from all site departments (Operations, M&D, Engineering, QC and QA), as well as corporate personnel and external suppliers. The position will require independent decisions and personal judgment based on company policies, SOPs, and GMPs.

Apply Now

Refine Your Search

analytical validation manager jobs in durham, nc

Principal Investigator

Business Intelligence III (Construction Ops)

HR Operations Analyst (Payroll & Compensation)

Senior Manager, HR Technology (Workday PATT)

IRT Project Coordinator / Associate Project Manager eCOA Technologies

Senior/Commercial Pricing and Contracting Manager, Market Access

Senior Manager Data Systems- EHS

HR Manager

Director, Global Resilience and Physical Security

Quality Engineer 2, Quality Operations - Clinical Laboratory # 4790

Sr. Director, R&D Chemistry

Category Manager, Clinical Contracts

Patient Account Team Lead - DUH ED

Metrologist

Marketing Engagement Associate Manager

Manager, Payroll N.A.

Business Development Associate - Pharmaceutical

External Manufacturing Senior Manager (DS/DP)

Laboratory Supervisor - Central Automated Lab - Third Shift

BCG Platinion | Manager, Enterprise Solutions – Advanced Planning Systems – Kinaxis

I want to receive the latest job alert for analytical validation manager in durham, nc

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