Manager, QA Systems

Catalent Pharma Solutions; Harmans (MD); On-site; USD 118,000 - 164,000; Full time

Job summary

An established industry player is seeking a Manager for Computer Systems Validation to ensure compliance with regulations and standards in a dynamic, fast-paced environment. This role involves providing quality oversight for various systems, supporting continuous improvement initiatives, and collaborating with multiple departments to enhance data integrity and validation processes. The ideal candidate will have extensive experience in QA, a strong understanding of FDA guidelines, and a passion for driving quality in the pharmaceutical sector. Join a leading organization dedicated to advancing life-saving products and making a meaningful impact in healthcare.

Benefits

Competitive medical benefits

401K

152 hours of PTO

8 Paid Holidays

Dynamic work environment

Opportunity for Continuous Improvement Processes

Qualifications

• 10 years of industry experience in QA and Computer Systems Validation.
• In-depth knowledge of FDA guidelines and Global cGMPs.

Responsibilities

• Oversee QA for computer systems validation and compliance.
• Collaborate with teams for training on data integrity initiatives.

Skills

Computer Systems Validation

Quality Assurance

FDA Guidelines

Data Integrity

Risk Management

Root Cause Analysis

Leadership

Collaboration

Education

Bachelor’s degree in Science or Engineering

Master’s degree in Science or Engineering

Tools

SCADA

Labvantage LIMS

Electronic Batch Records (eBR)

Manufacturing Execution System (MES)

Documentum

JDE Edwards

Job description

Manager, QA Systems

Position Summary:

The Manager – Computer Systems Validation is responsible for providing Quality oversight of Catalent’s Engineering, Quality Control, IT and Validation groups to ensure compliance with applicable US regulations, guidance's, industry standards and Catalent policies/procedures supporting the commercial GMP manufacturing of biological drug substance and drug product. The Manager – Computer Systems Validation will provide continuous improvement support to process equipment, utilities and computer systems and serve as the key Quality resource for the Engineering, Quality Control, IT and Validation organizations. The Manager – Computer Systems Validation will help support the quality review of validation project plans, user requirements, test strategies, electronic record and signature assessments and summary reports to address Validation lifecycle (including developing GxP computer system validation and CFR 21Part 11 related documentation).

The Role:

• Serve as the QA-CSV liaison with the Engineering, Quality Control, IT and Validation organizations to support SaaS enterprise computer systems validation of Gene therapy like but not limited to Apprentice Tempo Electronic Batch Records (eBR) and Manufacturing Execution System (MES) module along with other systems integrations, Lab vantage LIMS and LES modules, Electronic Laboratory Notebook (ELN), OpenText Documentum Electronic Document Management System (EDMS), MODA Software, JDE Edwards etc.
• Design and Software Development Life Cycle (SDLC) of the site automated systems including bioreactors, SCADA, OSISoft PI Data historian, Environmental Monitoring Systems, chromatography systems, AST Genesys Filling semi-automated machines, autoclaves and critical utilities. Review and approve equipment/software specifications including Configuration Specification (CS), User Requirement Specification (URS), Design and Functional Requirements (DS/FRS), qualification protocols including IQ/OQ/PQ and summary reports.
• Provide QA oversight for the site on global implementation of CSV policy and review System Impact Assessment (SIA), Data Integrity Assessments to ensure computer systems compliance with 21 CFR Part 11, Eudralex Annex 11 and applicable FDA/EMA Guidance's on electronic data integrity.
• Support GMP manufacturing Computer System Validation including Pall iCELLis, Cytiva, Sartorius, Thermo Fischer bioreactors, Beckam Cell counters and Repligen Tangential Flow Filtration and Sartorius Filter Integrity Testers, Wave and AKTA (Ready/Pilot) with unicon central networking systems, Sartorious Gen II/III bioreactors for use.
• Review and Approve lab computer systems validation documents to induct in the quality control laboratories includes PH meters, Total Organic Carbon, Double droplet PCR, Chemidoc, qPCR systems, Osmometers, Cell counters Vicell XR and Vicell Blue, Solo VPE, Bruker MALDI-TOF with Charles River database integration, Endo safe units etc.
• Provide QA oversight for Data Integrity Assessment for new systems as well as existing systems and its gap remediation like security, data management and disaster recovery.
• Provide QA support for the Infrastructure qualifications that include Files Share, Networks, switches, VLAN and applications like MOveIT. Support and maintain the validation status of the Backup, Restore, Archive Retrieval process, experience on the NAS Synology, Netback and Unitrends applications.
• Collaborate with manufacturing, engineering, validation, QC and IT to provide training and coaching on CSV projects and data integrity initiatives; Provide input into Requirements Specifications for inclusion of Data Integrity and CSV requirements while identifying data integrity risks and propose improvement plans.
• Serve as QA resource supporting the facility and equipment change management program, including review of applicable change controls to ensure appropriate activities are performed and documented supporting the introduction or change to equipment and facilities; Provide QA support for deviations related to Engineering, Facilities, Automation, IT, Quality Control and Validation groups. Perform Root Cause Analysis (RCA) and investigations to evaluate product impact and assist in identifying Corrective and Preventive Actions (CAPA) from the Deviations investigations.
• Support the Risk Management Program to evaluate and mitigate risks associated with equipment and facilities as appropriate using tools such as Failure Modes Effects and Analysis (FMEA), Fault Tree Analysis (FTA) or other available risk management tools.
• Serve as the QA-CSV resource for expansion projects which includes construction of cleanrooms, commissioning, and qualification of utilities such as HVACs, Process Gases, Water for Injection (WFI), automation systems and fill lines.
• Review and approve Standard Operating Procedures (SOPs) for the computers systems operation and administration and participate in site and corporate quality continuous process improvement initiatives; Support client and regulatory audits.
• Other duties as assigned.

The Candidate:

• Bachelor’s degree in a Science or Engineering field with 10 years of industry experience (or similar, relevant experience).
• Master’s degree in a Science or Engineering field with 5 years of experience preferred or similar experience highly desirable.
• In depth knowledge of FDA guidelines and Global cGMPs relevant to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE GAMP guidelines.
• Experience performing/supporting computer systems validations associated to IQ, OQ & PQ for software systems (SCADA, PI Historian, BMS, EMS, TrackWise, etc.).
• Experience working on Apprentice Tempo, Documentum, Labvantage LES, Labvantage GLIMS and SCADA.
• Able to work in a team setting and independently under minimum supervision, and have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.
• Experience with Facility Expansion and Data Integrity Remediation programs are a plus.
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

Pay (US ONLY, if location requires wage disclosure)

“The anticipated salary range for this position in Maryland is $118,720 - $163,240 plus bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.”

Why you should join Catalent:

• Competitive medical benefits and 401K
• 152 hours of PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes

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.

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