- A minimum of 6 years' experience in a Quality Assurance/ Quality Control role within a regulated, software environment
- Advanced-level understanding of quality management systems, including the writing of policies and procedures, auditing techniques and FDA regulations for clinical trial software
- Experience hosting and/or conducting audits of computerized systems within a clinical trial context
- Excellent client facing communication skills with ability to manage issue escalations, conflict negotiations and influence
- Excellent computer system validation, CAPA, Deviation Documentation, and Auditing skill
- Bachelor's Degree
- Experience in leading company-wide continuous improvement initiatives
- Extensive experience working in highly regulated GCP environments
- You'll create and reinforce a culture of quality within the company by being recognized as the subject expert of company compliance and the champion of continuous improvement and customer satisfaction
- You'll review, recommend, and lead the establishment of additional quality initiatives and/or quality systems for other areas of the organization, leading to improved customer satisfaction, improved efficiencies, and lower costs of operation
- You'll directly manage and ensure progress of audit team towards individual and department goals and initiatives and ensure staff qualifications remain current to defined standards
- You'll directly manage customer (Sponsor/client), internal and vendor audits
- You'll drive company-wide continuous improvement initiatives to improve customer satisfaction, product quality and cost of quality
- You'll establish and review internal measurements and metrics for product and service quality that support our mission and lead to extraordinary customer satisfaction
- You'll prepare and/or review product and process quality reports by collecting, analyzing, and summarizing information and trends, and collaborates with others to continually improve these operations
- You'll lead root-cause and corrective action investigations from audits and reporting and reviews efficacy of corrective actions, leading to overall reduction or elimination of non-conformances
- You'll complete audit and compliance requirements by training Quality Audit Team and monitoring their performance
- You'll maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies
- You'll support the company and customers during external inspections including audit assessment and QMS-related RFI question completion, as required
- You'll support/perform and/or lead Client (Customer), Internal, Regulated Body or Vendor Qualification audits, as required
- Generous paid time off
- Comprehensive benefits package largely subsidized by YPrime
- Flexible working arrangements with an emphasis on work/life balance
- 401(k) with company match
- Friendly, smart, passionate, and hard-working coworkers
- Opportunities for professional growth and advancement
-
Manager, Quality Audit
6 days ago
YPrime Malvern, United StatesIs your career in its prime? It could be · YPrime's Quality team is searching for a Quality Audit Manager to help manage YPrime's sponsor and client audit program, and to help lead and drive the organization's execution of a global regulatory and quality strategy. You'll be based ...
-
Quality Assurance Auditing Manager
21 hours ago
Resolian Malvern, United StatesJob Description · Responsibilities · •Manage performance and professional development of staff · •Oversee day to day function of department area · •Participate in evaluation and adaptation of new technologies as applicable · •Work alongside senior colleagues to define strate ...
-
Quality Assurance Auditing Manager
1 week ago
Resolian Malvern, United StatesJob DescriptionResponsibilities · •Manage performance and professional development of staff · •Oversee day to day function of department area · •Participate in evaluation and adaptation of new technologies as applicable · •Work alongside senior colleagues to define strategies for ...
-
Night Audit Supervisor
5 days ago
Newport Hospitality Group, Inc. Malvern, United States**Night Auditor** · **Night Audit Supervisor** · **Benefits** · - Insurance · - Paid time off · - 401K · - DailyPay: Access your pay when you need it · - An added plus; If you like to travel, you will receive special team member hotel rates. · This is a full time position, 5 days ...
-
Manager, Contact Center Customer Care
6 days ago
Cubesmart Malvern, United StatesOverview: · **This is a hybrid role in the Malvern, PA office.** · Who we are: · At CubeSmart, we're intentional about culture. You can experience it everywhere from our mission statement of "genuine care" to our "It's What's Inside That Counts" tagline to calling each other "tea ...
-
Night Auditor Full Time
1 week ago
Newport Hospitality Group, Inc. Malvern, United States Full time**Night Auditor** · **Night Auditor** · **Benefits** · - Insurance · - Paid time off · - 401K · - DailyPay: Access your pay when you need it · - An added plus; If you like to travel, you will receive special team member hotel rates. · This is a full time position, 5 days a week. ...
-
Category Manager
4 days ago
Saint Gobain Malvern, United States**The Role** · This Category Manager owns and manages the North American purchasing category for LTL and Full Truckload (Dry Van and Flatbed) within the logistics purchasing function. This position will handle all Less than Truckload (LTL) and Full truckload (FTL) category negoti ...
-
Balfour Beatty Investments - North America Malvern, United States**Who We Are** · Balfour Beatty Investments is a global infrastructure investor operating in the UK, US, and Canada. We provide the investment capability to deliver complex infrastructure projects. Over the past 15 years, Balfour Beatty Investments (formerly known as Balfour Beat ...
-
Regional Operations Manager
6 days ago
Balfour Beatty Investments - North America Malvern, United States**Who we are** · At Balfour Beatty Communities, we are dedicated to a singular mission: delivering the quality communities people are proud to call home. We believe exceptional living experiences can only be created when **We Care**—about our residents, our partners, our communit ...
-
Tax specialist
1 week ago
Radiant Ventures Traskwood, United StatesAbout the Company · We are an independent and partner-led auditing and tax consulting firm with locations in Munich, Dresden, and Chemnitz. We see ourselves as your partner in all tax and economic matters. · Our understanding of partnership has one goal: the long-term success of ...
-
Quality Auditor
3 days ago
The Chamberlain Group Inc Malvern, United StatesWe areSystems, LLCa leading manufacturer and designer of loading dock equipment.Wecontinue to GROW and are seeking a motivated team player to join our organization. · Job Summary: · As a Quality Auditor, you are expected to support and assist the supervisor with the coordinatio ...
-
Senior Quality Engineer
1 week ago
Pactiv Evergreen Malvern, United StatesOverview: · Pactiv Evergreen Inc. (NASDAQ: PTVE) is a leading manufacturer and distributor of fresh foodservice and food merchandising products and fresh beverage cartons in North America and certain international markets. It supplies its products to a broad and diversified mix ...
-
Senior Manufacturing Engineer
1 week ago
Pactiv Evergreen Malvern, United StatesOverview: · Pactiv Evergreen Inc. · (NASDAQ: PTVE) · is a leading manufacturer and distributor of fresh foodservice and food merchandising products and fresh beverage cartons in North America and certain international markets. It supplies its products to a broad and diversified ...
-
Chief Financial Officer
1 day ago
Almirall Malvern, United StatesAbout Almirall · We care. Through pharmaceutical innovation and a strong commitment to global healthcare partnerships, we are dedicated to providing the tools, knowledge and science to improve the health of patients worldwide. We research, develop, manufacture and market our own ...
-
Data Entry Associate
6 days ago
Infinia Search Inc Malvern, United StatesJob Description · Job DescriptionAt least a six month contract role with potential for extension/hire · Location: Malvern, PA · Start Date: 6/10/24 · Training Schedule: 8:30am-5:00pm Eastern Time – (Training will be hybrid, Mondays/Fridays-remote, Tue/Wed/Thu- on-site in Malvern ...
-
Pactiv Evergreen Malvern, United StatesOverview: Pactiv Evergreen Inc. (NASDAQ: PTVE) is a leading manufacturer and distributor of fresh foodservice and food merchandising products and fresh beverage cartons in North America and certain international markets. It supplies its products to a broad and diversified mix of ...
-
Quality Assurance Inspector
4 days ago
Havpak Inc Malvern, United StatesJob Description · Job Description1st and 2nd Shift · Role Description: · The Quality Control Inspector will assist the quality assurance department in implementing and supporting various GMP regulations throughout the facility with primary focus on in process inspections of manuf ...
-
Associate Director, Immunoassay
1 week ago
Resolian Malvern, United StatesJob Description · Responsibilities: · •Manage performance and professional development of staff · •Oversight and leadership of multiple managers, departments, or sites as appropriate · •Provide guidance and decision-making on scientific, operational, and regulatory issues, as a ...
-
Pactiv Evergreen Malvern, United StatesOverview: · Pactiv Evergreen Inc. (NASDAQ: PTVE) is a leading manufacturer and distributor of fresh foodservice and food merchandising products and fresh beverage cartons in North America and certain international markets. It supplies its products to a broad and diversified mix ...
-
Pactiv Evergreen Malvern, United StatesOverview: Pactiv Evergreen Inc. (NASDAQ: PTVE) is a leading manufacturer and distributor of fresh foodservice and food merchandising products and fresh beverage cartons in North America and certain international markets. It supplies its products to a broad and diversified mix of ...
Manager, Quality Audit - Malvern, United States - YPrime
Description
Job Description
Job DescriptionAt YPrime, we help our clients in the pharma and biotech industries to collect data from patients using mobile devices, assign patients to study treatment groups, and dispense clinical trial drugs and supplies using web apps. We're supporting life-altering research, one project at a time.
Is your career in its prime? It could be
YPrime's Quality team is searching for a Quality Audit Manager to help manage YPrime's sponsor and client audit program, and to help lead and drive the organization's execution of a global regulatory and quality strategy. You'll be based in our Malvern, Pennsylvania headquarters.
At YPrime, we help our clients in the Pharma and Biotech industries to collect data from patients using mobile devices, assign patients to study treatment groups, and dispense clinical trial drugs and supplies using web applications. We're supporting life-altering research, one project at a time.
Does our mission sound like something you can get behind? If so, here's what we need from you:
Have these things too? Even better
Here are some more details about the job:
What are the Prime Perks?
