Principal GCP Quality Assurance Auditor at Precision Medicine Group (View all jobs) Remote, United States Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages-from early development through approval-with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Won't you join us today as a Principal Quality Assurance Auditor? Position Summary: The Principal Quality Auditor is responsible for providing senior oversight and subject matter expertise to quality and compliance activities, supporting the Q&C Management team, Q&C team members, and the project teams during all stages of a clinical study. Essential functions of the job include but are not limited to:
- Serve as a subject matter expert for clinical project teams
- Uses ability and specialized skill to complete difficult tasks. Develops and implements concepts and/or techniques to achieve objectives
- Understands Precision processes and functional SME organization to work through complex tasks independently to resolution
- Support the Quality Management System including SOPs, training and CAPA
- Attends project meetings, representing Quality. Reviews project plans and provides compliance guidance on complex issues independently.
- Process and maintain documentation for controlled documents, as required
- Develop and administer training for employees and/or consultants
- Host client/sponsor audits and support regulatory inspections
- Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted
- Coordinate and conduct internal audits of quality systems
- Coordinate and conduct investigator site audits
- Coordinate and conduct trial master file audits
- Participate on computer systems validation projects and systems change control process
- Monitor quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement
- Maintains Q&C trackers, databases, metrics, and files
- Follow applicable regulations and standards, including but not limited to local regulations (US FDA and EU), ICH and company policies and procedures
- Support Proposals and Bid Defense meetings as needed
- Additional tasks as required
Qualifications: Minimum Required:
- 5 years of experience
- Working knowledge of GCP/ICH guidelines and FDA regulations and standards
- Audit experience conducting a variety of audit types, including internal systems, vendors, TMF and investigator site audits.
Other Required:
- Bachelor's degree in a science, healthcare, or related field of study; combination of qualifications and equivalent relevant experience may be accepted as an alternative
- Availability to travel up to 25% domestically and/or internationally
Preferred:
- CRO, Pharmaceutical and/or Medical device experience
- QA certification preferred (e.g., CQA, SQA, etc.)
- Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.)
Skills:
- Excellent interpersonal and problem-solving skills, effective verbal and written communication, computer skills
Competencies
- Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient.
- Demonstrates mastery knowledge of ICH-GCP, relevant Precision SOPs, and compliance guidance, as well as the ability to implement
- Proficient in Microsoft Word, Excel, and PowerPoint
- Ability to support senior leadership in Q&C Management tasks and projects, offering solutions and processes for increased efficiencies within the department.
- Ability to develop, coach and mentor Q&C staff.
- Demonstrates a solid working knowledge of e-Clinical systems/platforms.
- Demonstrates strong interpersonal skills.
- Ability to lead and inspire excellence within a team
- Results oriented, accountable, motivated and flexible
- Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.
- Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, possess good. interpersonal skills and maintain positive interactions with internal and external stakeholders.
- Demonstrates values and a work ethic consistent with Precision Values and Company Principles.
- Excellent verbal and written communications skills
#LI-RemotePrecision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range $96,500 - $144,700 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at ...@precisionmedicinegrp.com . It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.