QA Validation Manager

3 weeks ago

Malvern, United States Marken Full time
Description

Title

QA Validation Manager

Main Purpose

The QA Validation Manager/Sr. Manager is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes, and policies required to manage validation life cycles, calibration and maintenance of equipment/facilities used in support of Marken's global storage, distribution, and logistics operations.

The QA Validation Manager/Sr. Manager will also need to ensure compliance with applicable regional and local regulations including but not limited to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), Good Documentation Practices (GdocP), ISO 13485, and ISO 9001.

Lead a team that will maintain, execute, and monitor the global validation/qualification program, including ownership of the validation master plan, re-qualification schedules, and documentation management.

Main Duties and Responsibilities
  • Perform/Support the introduction of equipment, systems, and processes through the validation lifecycle process including but not limited to evaluation, design (URS), installation, operational and performance qualification (IQ/OQ/PQ), calibration and maintenance requirements of equipment, facilities, and utility systems.
  • Create, review and/or approve internal validation (VMP, URS, IQ, OQ, PQ protocols, reports, etc), and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
  • Agree and define the quality processes and procedures associated with job role through strategic planning and effective controlled document approval.
  • Review and approve vendor supplied calibration and maintenance documentation for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
  • Maintain and monitor the requalification, calibration, and maintenance schedules.
  • Coordinate with equipment owners and external venders to always maintain equipment and facilities in a compliant state.
  • Supports site operational teams during fieldwork and execution of validation protocols.
  • Evaluate the risk and impact of equipment/facility changes to the validated, calibrated, and maintained status and advise on necessary actions, as applicable.
  • Solves complex validation execution issues using critical analysis skills and develops sound, reasoned solutions and recommendations.
  • Support/Lead complex Marken deviations, CAPAs, risk assessments, and change control.
  • Create and deliver training on execution of validation requirements, as applicable.
  • Support internal and external audits (e.g., client and regulatory inspections), including the preparation of appropriate documentation, participation as a Subject Matter Expert (SME), when applicable.
  • Identify quality KPIs, collate KPI data and reporting associated with Marken's validation, calibration, and maintenance program. Evaluate KPI metrics to monitor and drive continuous improvement.
  • Knowledgeable in 21 CFR Part 11. Provides QA oversight and expertise to computer system validation (CSV) projects across Marken's Global Network led by the CSV-IT Department.
  • Keep informed of regulatory trends, changes in Country/Region and lead the evaluation of changes to internal Marken processes.
  • Travel may be required for the performance of duties.
General
  • Fluent In English. Multi-lingual (desired), dependent on recruiting area.
  • Comprehensive knowledge of GxP regulations - Good Manufacturing Practices and/or Good Distribution Practices.
  • Implement and maintain company's quality systems at the facility, in compliance with Marken's Global Quality Management System (QMS) requirements.
  • Demonstrated ability to effectively communicate and collaborate across all levels of the organization including with employees, leadership teams, customers, vendors, equipment suppliers, and operations staff.
  • Organized, methodical and efficient approach to work.
  • Excellent verbal, written, and interpersonal communication skills.
  • Demonstrated people management skills including training, coaching, motivating, active listening, building trust, conflict resolution skills, ability to prioritize and delegate tasks, manage day-to-day tasks of employees to ensure on-time performance of company goals.
  • Perform activities assigned by the QA Director.
  • Support QA team to ensure a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
Requirements
  • Organized, methodical and efficient approach to work.
  • Excellent verbal, written, and interpersonal communication skills.
  • Demonstrated people management skills.
  • Demonstrated ability to effectively communicate and collaborate across all levels of the organization including with employees, customers, vendors, equipment suppliers, and Operations staff.
  • Proficient use of Microsoft Office
  • Hands on experience with temperature monitoring devices
  • Temperature mapping of CTU's (controlled temperature units)
  • Computer System Validation
  • Bachelor's degree required.
  • 5+ years (Manager)/6+ years (Sr. Manager) of relevant validation experience and/or quality experience in a GxP industry or the equivalent combination of relevant education and professional experience.


Marken is a wholly owned subsidiary of UPS and is a critical part of UPS Healthcare. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution worldwide, and supports cell and gene therapy logistics services from clinical to commercial, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments and biological kit production.

Moving Our World Forward by Delivering What Matters.

EEO & Veteran Employer

  • QA Engineer

    2 weeks ago

    Malvern, United States Tential Full time

    Help the world buy it and go FinTech company that is constantly evolving the way companies across the globe manage, optimize, and automate the critical decisions made on a daily basis. We are committed to helping businesses grow smarter, better, and faster than ever before. Our vision is to ultimately help the world buy it and go. LOCATION IS ATLANTA,...

  • QA Associate

    2 weeks ago

    Malvern, United States Insight Global Full time

    Contracted Opportunity through the End of 2024 (Potential to be extended)Compensation: $35/hr to $40/hr. Exact compensation may vary based on several factors, including skills, experience, and education.Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA...

  • QA Associate

    1 week ago

    Malvern, United States Insight Global Full time

    Contracted Opportunity through the End of 2024 (Potential to be extended)Compensation: $35/hr to $40/hr. Exact compensation may vary based on several factors, including skills, experience, and education.Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA...

  • QA Associate

    7 days ago

    Malvern, United States Insight Global Full time

    Contracted Opportunity through the End of 2024 (Potential to be extended)Compensation: $35/hr to $40/hr. Exact compensation may vary based on several factors, including skills, experience, and education.Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA...

  • Business Intelligence QA Analyst I

    1 week ago

    Malvern, United States iSpace Full time

    Title: Business Intelligence QA Analyst (Data Integration) Location: Malvern, PA (Hybrid 3 days onsite each month, 2 nd full week of the month on Tuesday, Weds, and Thursday and then the rest of the work will be remote. Onsite could become more frequent in the future) Duration: 3-month contract with strong possibility of an extension This QA...

  • Business Intelligence QA Analyst I

    1 week ago

    Malvern, United States iSpace Full time

    Title: Business Intelligence QA Analyst (Data Integration) Location: Malvern, PA (Hybrid 3 days onsite each month, 2 nd full week of the month on Tuesday, Weds, and Thursday and then the rest of the work will be remote. Onsite could become more frequent in the future) Duration: 3-month contract with strong possibility of an extension This QA...

  • Business Intelligence QA Analyst I

    3 weeks ago

    Malvern, United States iSpace Full time

    Title: Business Intelligence QA Analyst (Data Integration) Location: Malvern, PA (Hybrid 3 days onsite each month, 2 nd full week of the month on Tuesday, Weds, and Thursday and then the rest of the work will be remote. Onsite could become more frequent in the future) Duration: 3-month contract with strong possibility of an extension This QA Analyst will be...

  • Business Intelligence QA Analyst

    1 month ago

    Malvern, United States Compri Consulting Full time

    Business Intelligence QA Analyst Remote, 1 day per month on-site in MalvernCompri Consulting is hiring a Business Intelligence QA Analyst for a 4+ month contract opportunity. Open to Local Malvern, PA candidates.Duties: Review requirements and design documents with developers and quality assurance manager to confirm expected functionality with technical and...

  • Business Intelligence QA Analyst

    1 month ago

    Malvern, United States Compri Consulting Full time

    Business Intelligence QA Analyst Remote, 1 day per month on-site in MalvernCompri Consulting is hiring a Business Intelligence QA Analyst for a 4+ month contract opportunity. Open to Local Malvern, PA candidates.Duties: Review requirements and design documents with developers and quality assurance manager to confirm expected functionality with technical and...

  • Business Intelligence QA Analyst

    1 month ago

    Malvern, United States Compri Consulting Full time

    Business Intelligence QA Analyst Remote, 1 day per month on-site in MalvernCompri Consulting is hiring a Business Intelligence QA Analyst for a 4+ month contract opportunity. Open to Local Malvern, PA candidates.Duties: Review requirements and design documents with developers and quality assurance manager to confirm expected functionality with technical and...

  • Validation Engineer

    1 week ago

    Malvern, United States Valspec Full time

    Validation Engineer Valspec is the leading provider of computer system validation services in the greater Philadelphia area. We specialize in validating Emerson technology, including the Emerson DeltaV distributed control system and Syncade manufacturing execution system. Our team of experts ensures that our clients' systems meet regulatory requirements and...

  • Validation Engineer

    1 week ago

    Malvern, United States Valspec Full time

    Job DescriptionJob DescriptionValspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle...

  • Validation Engineer

    2 days ago

    Malvern, United States Valspec Full time

    Job DescriptionJob DescriptionValspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle...

  • QA Engineer

    2 weeks ago

    Malvern, United States Georgia IT Inc Full time

    QA Engineer - Malvern PA (back Fill) Position Type : 06 Months plus contract Rate: DOE Start -Immediately U.S. Citizens and those authorized to work in the U.S. are encouraged to apply. We are unable to sponsor at this time. Job Description Leads facilitation of the team collaboration sessions to gather information at the right level of detail and scope to...

  • Quality Assurance Associate

    2 weeks ago

    Malvern, United States Insight Global Full time

    Required Skills and Experience:-Bachelor's Degree required in Science, or equivalent technical subject area-5-7 years of experience working within the pharmaceutical field within QA activities (quality oversight) in GMP manufacturing-Strong experience working with change controlsNice to Have Skills and Experience:-Clinical product experience-GMP...

  • Quality Assurance Associate

    2 weeks ago

    Malvern, United States Insight Global Full time

    Required Skills and Experience:-Bachelor's Degree required in Science, or equivalent technical subject area-5-7 years of experience working within the pharmaceutical field within QA activities (quality oversight) in GMP manufacturing-Strong experience working with change controlsNice to Have Skills and Experience:-Clinical product experience-GMP...

  • Quality Assurance Associate

    2 weeks ago

    Malvern, United States Insight Global Full time

    Required Skills and Experience:-Bachelor's Degree required in Science, or equivalent technical subject area-5-7 years of experience working within the pharmaceutical field within QA activities (quality oversight) in GMP manufacturing-Strong experience working with change controlsNice to Have Skills and Experience:-Clinical product experience-GMP...

  • Quality Assurance Associate

    23 hours ago

    Malvern, United States Insight Global Full time

    Required Skills and Experience:-Bachelor's Degree required in Science, or equivalent technical subject area-5-7 years of experience working within the pharmaceutical field within QA activities (quality oversight) in GMP manufacturing-Strong experience working with change controlsNice to Have Skills and Experience:-Clinical product experience-GMP...

  • Quality Assurance Associate

    2 weeks ago

    Malvern, United States Insight Global Full time

    Requirements: -Bachelor’s Degree required; focused degree preferred in Engineering, Science, or equivalent technical subject area-5-7 years of experience working within the pharmaceutical field within QA activities (quality oversight) in GMP manufacturing-Strong experience working with change controlsPreferred:-Clinical product experience-GMP Manufacturing...

  • Quality Assurance Associate

    2 weeks ago

    Malvern, United States Insight Global Full time

    Requirements: -Bachelor’s Degree required; focused degree preferred in Engineering, Science, or equivalent technical subject area-5-7 years of experience working within the pharmaceutical field within QA activities (quality oversight) in GMP manufacturing-Strong experience working with change controlsPreferred:-Clinical product experience-GMP Manufacturing...