Expect more from your career. Expect PPD.
PPD Laboratories offer the most comprehensive set of laboratory services available in the industry. Our services are designed to accelerate pharmaceutical development for small molecules, biologics, and vaccines, allowing our clients to make faster decisions about their compounds.
*Note: This position is based in PPD's GMP Laboratory in Middleton, WI.
As a Sr. Quality Assurance (QA) -Data Integrity, you will:
- Represent the global quality and compliance department with expertise in Data Integrity.
- Perform Data Integrity risk assessment of laboratory systems.
- Prioritize risks and work with IT, QA, and Laboratory personnel to address Data Integrity gaps.
- Maintain currency with U.S. and European regulations related to Data Integrity.
- Prepare, maintain, and deliver presentation materials to client and regulators for Data Integrity subject matter.
- Represent PPD in client and regulatory audits related to Data Integrity.
- Facilitate the completion of client questionnaires related to Data Integrity.
- Establish a firm understanding of PPD IT Infrastructure, assesses proposed changes for Data Integrity implications, and recommends infrastructure changes to enhance Data Integrity.
- Evaluate proposed and existing instrument systems and laboratory applications for Data Integrity gaps. Works with IT and QA to resolve those gaps.
- On occasion, may require on-call availability outside of U.S. business hours to support overseas audits.
Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines and fulfill client and PPD requirements.
Support business leaders in mitigating risk.
- Build relationships between on-site QA services and QA management of designated clients.
Minimum Required Education and Experience:
- Bachelor’s degree (or equivalent) required in a relevant scientific discipline
- Relevant quality assurance experience (comparable to 10+ years) including expertise in GMP regulations gained from time served in a pharmaceutical, biotechnology and/or medical device industry
- Demonstrated experience providing customer-related QA services preferably in a contract services environment
- Possess or working towards a Certified Quality Auditor designation or be certified/registered in another recognized/relevant organization
5+ years working in a GMP regulated environment
3+ years of experience working with Information Technology and a fundamental understanding of IT concepts
3+ years of experience in a computer systems validation or quality assurance role
Or equivalent combination of education, training and experience that provides the knowledge, skills and abilities to perform the duties of the job.
Required Knowledge, Skills and Abilities:
Working knowledge of applicable GMP regulations, particularly 21 CFR Part 11, Eudralex Volume 4 Annex 11, and current FDA/MHRA guidance on Data Integrity
Proficiency in Microsoft Office (Word, Excel, PowerPoint)
Expertise in all aspects of pharmaceutical GMP regulations (e.g. quality systems, root cause analysis and Total Quality Management)
- Knowledge of all GMP regulations including international regulations
- Knowledge of applicable parts of 21 CFR regulations
- May require knowledge of ISO standards where applicable
- Ability to handle multiple and changing priorities and tight deadlines while remaining detail-oriented
- Good verbal and written communication skills
- Proactive approach to core competencies of the role
- Ability to work independently with minimal supervision.
Working Conditions and Environment:
- Work is performed in an office environment with exposure to electrical office equipment.
- Travel required up to 30% including international.
- Frequent interaction with clients/associates.
- Variable work hours to accommodate lab and audit schedules.
- Ability to work in an upright and /or stationary position for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Frequent mobility required.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacts with others to obtain or relate information to diverse groups.
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.
- Ability to perform under stress.
- Ability to multi-task.
- Regular and consistent attendance.