Catalent
Manager Computer System Validation and Data Integrity
Catalent, Franklin Park, New Jersey, United States
Manager Computer System Validation and Data Integrity
Join to apply for the
Manager Computer System Validation and Data Integrity
role at
Catalent Manager Computer System Validation and Data Integrity
Join to apply for the
Manager Computer System Validation and Data Integrity
role at
Catalent Get AI-powered advice on this job and more exclusive features. INTERNET POSTING
__________________________________________________________________
INTERNET POSTING
__________________________________________________________________
Job Title:
Manager Computer System Validation and Data Integrity
City:
Somerset
State : NJ
JOB DESCRIPTION :
Coordinate with project teams, suppliers, site quality and IT teams acting as an expert on quality, regulatory, and compliance resource, bringing forth opportunities for the implementation of new world-class systems and leverage existing systems for the assurance of GMP Manufacturing to help support the growth of the business; Provide quality and regulatory oversight of the design, development, validation, implementation and ongoing maintenance and use of computerized GxP systems and IT infrastructure; Oversee quality and regulatory assessments, change controls, periodic reviews, investigations, deviations and CAPAs relating to computerized GxP systems; Assure quality and regulatory compliance of global teams and sites; Provide quality and regulatory data integrity program management, oversight and training for global teams, systems and sites; Identify compliance and process improvements based upon internal and external audit observations and regulatory surveillance; Collaborate on the development and maintenance of Global Quality and CSV Polices, Standards and Procedures as well as participating in associated roll out and training; and Participate in internal and supplier audits as a compliance, IT and CSV subject matter expert and supporting regulatory and client audits of global systems and sites.
EDUCATION AND
EXPERIENCE : Requires a Bachelor’s degree in Drug Regulatory Affairs and 3 years of experience in job offered or 3 years of experience in the Related Occupation.
RELATED OCCUPATION:
Validation Analyst or any other job title performing all listed job duties.
JOB TIME : Full Time
SALARY RANGE:
$118,200 to $206,900/year
Catalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Information Technology Industries Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Catalent by 2x Sign in to set job alerts for “Computer System Manager” roles.
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We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Join to apply for the
Manager Computer System Validation and Data Integrity
role at
Catalent Manager Computer System Validation and Data Integrity
Join to apply for the
Manager Computer System Validation and Data Integrity
role at
Catalent Get AI-powered advice on this job and more exclusive features. INTERNET POSTING
__________________________________________________________________
INTERNET POSTING
__________________________________________________________________
Job Title:
Manager Computer System Validation and Data Integrity
City:
Somerset
State : NJ
JOB DESCRIPTION :
Coordinate with project teams, suppliers, site quality and IT teams acting as an expert on quality, regulatory, and compliance resource, bringing forth opportunities for the implementation of new world-class systems and leverage existing systems for the assurance of GMP Manufacturing to help support the growth of the business; Provide quality and regulatory oversight of the design, development, validation, implementation and ongoing maintenance and use of computerized GxP systems and IT infrastructure; Oversee quality and regulatory assessments, change controls, periodic reviews, investigations, deviations and CAPAs relating to computerized GxP systems; Assure quality and regulatory compliance of global teams and sites; Provide quality and regulatory data integrity program management, oversight and training for global teams, systems and sites; Identify compliance and process improvements based upon internal and external audit observations and regulatory surveillance; Collaborate on the development and maintenance of Global Quality and CSV Polices, Standards and Procedures as well as participating in associated roll out and training; and Participate in internal and supplier audits as a compliance, IT and CSV subject matter expert and supporting regulatory and client audits of global systems and sites.
EDUCATION AND
EXPERIENCE : Requires a Bachelor’s degree in Drug Regulatory Affairs and 3 years of experience in job offered or 3 years of experience in the Related Occupation.
RELATED OCCUPATION:
Validation Analyst or any other job title performing all listed job duties.
JOB TIME : Full Time
SALARY RANGE:
$118,200 to $206,900/year
Catalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Information Technology Industries Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Catalent by 2x Sign in to set job alerts for “Computer System Manager” roles.
Somerset, NJ $84,500.00-$135,100.00 2 weeks ago Patient Services System Manager - Commercial IT - Job ID: PSSM
Princeton, NJ $145,000.00-$155,000.00 2 weeks ago Princeton, NJ $80,000.00-$130,000.00 2 weeks ago Network and Computer System Administrator
Edison, NJ $89,586.00-$255,944.00 1 month ago Princeton, NJ $78,700.00-$98,400.00 2 weeks ago Princeton, NJ $74,000.00-$80,000.00 1 week ago Princeton, NJ $62,000.00-$116,000.00 2 weeks ago Ewing, NJ $95,000.00-$135,000.00 1 week ago Piscataway, NJ $106,400.00-$150,000.00 1 week ago Princeton, NJ $75,000.00-$120,000.00 6 months ago Sales Systems Territory - Northeast Manager Radiography NDT
Trenton, NJ $88,800.00-$199,500.00 2 weeks ago Morristown, NJ $144,200.00-$265,600.00 6 days ago Princeton, NJ $144,200.00-$265,600.00 6 days ago Full Time Assistant Store Manager (Store 6180)
North Brunswick, NJ $18.24-$22.24 2 days ago Full Time Assistant Store Manager (Store 2700)
South Plainfield, NJ $18.24-$22.24 2 days ago Full Time Assistant Store Manager (Store 1397)
Full Time Assistant Store Manager (Store 4330)
East Brunswick, NJ $18.24-$22.24 2 days ago Full Time Assistant Store Manager (Store 4756)
Full Time Assistant Store Manager (Store 4771)
Full Time Assistant Store Manager (Store 4720)
Full Time Assistant Store Manager (Store 6765)
Full Time Assistant Store Manager (Store 4712)
Full Time Assistant Store Manager (Store 6424)
Full Time Assistant Store Manager (Store 4956)
Full Time Assistant Store Manager (Store 6085)
Full Time Assistant Store Manager (Store 4751)
Full Time Assistant Store Manager (Store 6027)
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr