Talent.com
Director, QA Data Integrity
Director, QA Data IntegrityThermo Fisher • El Paso, TX, US
serp_jobs.error_messages.no_longer_accepting
Director, QA Data Integrity

Director, QA Data Integrity

Thermo Fisher • El Paso, TX, US
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

The QA Director, Global Data Integrity Program will own the Global DI Program that ensures compliance to regulatory requirements at all Pharmaceutical Services Group (PSG) sites. In addition to ensuring implementation at all sites, the candidate will drive practical improvements and will develop and monitor Key Performance Indicators to measure the effectiveness of the program.

Education / Experience

  • Bachelor's Degree or higher in Pharmacy, Engineering, Science or other applicable degree with relevant work experience.
  • 10 years plus experience in pharmaceutical manufacturing, or pharmaceutical laboratory testing with confirmed experience leading data integrity programs.
  • Proficient in the application of 21CFR Part 11, Annex 11 and other applicable regulations

What You Will Do :

  • Stay current on global regulations and expectations and industry trends related to data integrity. Update global policies and procedures and other program elements to maintain a state of regulatory compliance.
  • Help sites resolve challenges in program implementation, instrument / equipment remediation, etc.
  • Stay current with industry standard processes through benchmarking and active participation in industry groups such as PDA and ISPE.
  • Lead a Global Community of Practice for information sharing between sites.
  • Assist sites with data integrity risk assessments and mitigation plans.
  • Analyze metrics and address trends to Site Quality Heads and General Managers and Division Quality VPs.
  • Use PPI (Practical Process Improvement) methodology to develop or improve processes that enable sites to improve documentation and data integrity requirements.
  • Support sites in explaining the Data Integrity Program for regulatory and client audits as needed.
  • Develop training content that global and site training coordinators can deploy.
  • Take on other duties / projects as assigned to support the Global Quality Compliance Team as required.

    • Knowledge, Skills, Abilities

  • Proven ability to influence and lead professional multidisciplinary staff in order to achieve goals.
  • Experience with external surveillance and searching for latest information related to data integrity and quality culture.
  • Ability to evaluate and resolve complex technical problems by using network resources.
  • Ability to drive functional, technical, and operational excellence.
  • Work independently with little supervision, especially remotely.
  • Ability to develop an internal strategic network while working remotely.
  • Proficiency in Microsoft Office Suite (Teams, Word, Excel, PowerPoint, etc.).
  • Strong written and verbal communication skills and effective presentation skills with specific emphasis on upwards communication.

    • Physical Requirements

  • This position requires ability to work with computer systems.
  • 25-50% domestic and / or international travel may be required.
  • Ability to clearly communicate verbally via Web-based conferencing platforms.

    • Compensation and Benefits

    The salary range estimated for this position based in North Carolina is $145,500.00-$218,250.00. This position may also be eligible to receive a variable annual bonus based on company, team, and / or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes :

  • A choice of national medical and dental plans, and a national vision plan, including health incentive programs
  • Employee assistance and family support programs, including commuter benefits and tuition reimbursement
  • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
  • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
  • Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

    • For more information on our benefits, please visit : https : / / jobs.thermofisher.com / global / en / total-rewards

    serp_jobs.job_alerts.create_a_job

    Director Qa Data Integrity • El Paso, TX, US

    Job_description.internal_linking.related_jobs
    Senior Director of Enterprise Application Architecture

    Senior Director of Enterprise Application Architecture

    Confidential • El Paso, TX, US
    serp_jobs.job_card.full_time
    Senior Director of Enterprise Application Architecture.Industry-leading legal technology specialist.Information Technology and Services. The Senior Director of Enterprise Application Architecture wi...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Vice President of Data Science & Analytics

    Vice President of Data Science & Analytics

    Confidential • El Paso, TX, US
    serp_jobs.job_card.full_time
    Vice President of Data Science & Analytics.Prominent healthcare provider serving the local community.The Company is seeking a VP of Data Science and Analytics to play a pivotal role in shaping ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Vice President of Data & ML Platforms (El Paso)

    Vice President of Data & ML Platforms (El Paso)

    Confidential • El Paso, TX, US
    serp_jobs.job_card.part_time
    Vice President of Data & ML Platforms.Popular manufacturer, distributer & marketer of automobiles.The Company is seeking a Vice President of Data & ML Platforms to spearhead its digital transformat...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Senior Director of Product

    Senior Director of Product

    Confidential • El Paso, TX, United States
    serp_jobs.job_card.full_time
    Successful healthcare tech company.The Company is seeking a Sr Director of Product to lead their Research Data Organization in the development of a software platform that supports the creation and ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Director of Product

    Director of Product

    Confidential • El Paso, TX, US
    serp_jobs.job_card.full_time
    Innovative software product studio.Information Technology and Services.The Company is seeking a Director of Product to join their dynamic team. The successful candidate will be responsible for the f...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Managing Director, Data (El Paso)

    Managing Director, Data (El Paso)

    Confidential • El Paso, TX, US
    serp_jobs.job_card.part_time
    Innovative digital media agency.Privately Held, Private Equity-backed.Information Technology & Services.Consulting & Professional Services. The Company is seeking a Managing Director, Data to play a...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Remote Content QA Reviewer

    Remote Content QA Reviewer

    Outlier • El Paso, TX, United States
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Vice President Data & Trisus Platform Engineering

    Senior Vice President Data & Trisus Platform Engineering

    Confidential • El Paso, TX, United States
    serp_jobs.job_card.full_time
    Senior Vice President Data & Trisus Platform Engineering.Innovative healthcare revenue cycle management (RCM) software provider. The Company is seeking a Senior Vice President for Data and Platform ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Senior Director of Enterprise Information Systems

    Senior Director of Enterprise Information Systems

    Confidential • El Paso, TX, US
    serp_jobs.job_card.full_time
    Senior Director of Enterprise Information Systems.Expanding restaurant franchisor.The Company is seeking a Senior Director of Enterprise Information Systems to play a pivotal role in defining and m...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Vice President of Data & Machine Learning Platforms

    Vice President of Data & Machine Learning Platforms

    Confidential • El Paso, TX, US
    serp_jobs.job_card.full_time
    Vice President of Data & Machine Learning Platforms.Popular manufacturer, distributer & marketer of automobiles.The Company is seeking a Vice President of Data & ML Platforms to spearhe...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Director of Customer Success

    Director of Customer Success

    Confidential • El Paso, TX, US
    serp_jobs.job_card.full_time
    Fast-growing technology company.Information Technology and Services.The Company is in search of a Director of Customer Success to join their dynamic team. The successful candidate will be responsibl...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Director of Data Center Engineering

    Director of Data Center Engineering

    Confidential • El Paso, TX, United States
    serp_jobs.job_card.full_time
    Director of Data Center Engineering.A leading AI infrastructure company dedicated to innovation.Information Technology and Services. Join us as the Director of Data Center Engineering, where you wil...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Global Director

    Global Director

    Confidential • El Paso, TX, US
    serp_jobs.job_card.full_time
    Well-established igaming company.The Company is seeking a Global Director with a strong background in mathematical testing within the gaming industry. The successful candidate will be responsible fo...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Work From Home -Remote Content QA Reviewer

    Work From Home -Remote Content QA Reviewer

    Outlier • El Paso, TX, United States
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Managing Director, Data

    Managing Director, Data

    Confidential • El Paso, TX, United States
    serp_jobs.job_card.full_time
    Innovative digital media agency.Privately Held, Private Equity-backed.Information Technology & Services.Consulting & Professional Services. The Company is seeking a Managing Director, Data to play a...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Vice President of Data & ML Platforms

    Vice President of Data & ML Platforms

    Confidential • El Paso, TX, US
    serp_jobs.job_card.full_time
    Vice President of Data & ML Platforms.Popular manufacturer, distributer & marketer of automobiles.The Company is seeking a Vice President of Data & ML Platforms to spearhead its digital...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Executive Director, Quality Assurance

    Executive Director, Quality Assurance

    Confidential • El Paso, TX, US
    serp_jobs.job_card.full_time
    Executive Director, Quality Assurance.Innovative biotech company developing selective monoclonal antibodies for rare autoimmune diseases. The Company is seeking an Executive Director for Quality Ass...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Executive Director, Clinical Quality Assurance

    Executive Director, Clinical Quality Assurance

    Confidential • El Paso, TX, US
    serp_jobs.job_card.full_time
    Executive Director, Clinical Quality Assurance.Innovative biopharmaceutical company.The Company is seeking an Executive Director for Clinical Quality Assurance (CQA) to lead and oversee all aspects...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new