Clinical Quality Assurance Lead

ProPharma•Chicago, IL

2d•Remote

About The Position

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. Host and/or Support CRS/FSP client audit and/or regulatory authority inspection (audits/inspections) activities including but not limited to audit/inspection preparation, conduct, reporting, serve as SME for applicable quality topics, CAPA review/approval/ completion, and eQMS record management activities. Develop responses to CAPAs arising from client/inspections, as applicable to CQA, and tracks to completion and closure. Collaborate with multiple lines of business to prepare for/conduct audits/inspections. Coordinate Client Questionnaire Audits and serve as SME for applicable quality topics Perform review and approval of Deviations, Quality Events, CAPAs, and Effectiveness Checks in the eQMS. Support CRS/FSP project leadership in setup and subscription of Client and/or project-specific Deviation, Quality Event, and CAPA eQMS reports for Client provision, as contractually obligated. Conduct periodic review of Deviation, Quality Event, and CAPA eQMS reports to facilitate identification of emerging trends. Escalate emerging trends to Management for improvement opportunities. Perform GxP change management activities including risk and impact analysis review, change plan review and approval, action implementation to completion, and eQMS record management. Provide ongoing GxP Subject Matter Expertise (SME) to CRS/FSP staff including but not limited to consulting on regulatory requirements and guidance and components of the ProPharma QMS. Participate in CRS/FSP Client operational meetings requiring CQA representation. Contribute to the creation of controlled documents such as SOPs and Work Instructions. Perform quality review and approval of CRS/FSP and/or Quality Assurance controlled documents. Collaborate in the review and approval of CRS/FSP computerized systems related validation documentation in the eQMS. Identify any issues which could potentially impact services and escalates any areas of concern within the business to Management, with potential corrective actions. Support the delivery of the internal quality program including quality assurance and quality control. Maintain awareness of and ensure adherence to applicable SOPs/ controlled documents, applicable GxP regulations, and client agreements. Perform other duties as required.

Requirements

Advanced computer skills including experience with Microsoft Office (Outlook, Word, Excel, PowerPoint, Teams, etc.) and Adobe Acrobat application are required.
Knowledge and experience in working with GxP QMS including but not limited to record management, reporting, and data analytics.
Willing to train internally or externally on the fundamentals of working within a regulated eQMS.
Able to communicate quality issues to non-quality staff at all levels of the company in a clear and concise manner.
Excellent verbal, written, presentation skills, and interpersonal communication skills with the ability to establish and sustain professional relationships with clients and internal staff.
Ability to critically evaluate and troubleshoot complex problems with diligence while integrating stakeholder input and feedback.
Highly responsible, self-motivated professional with enthusiasm with a passion for GxP work.
Exceptional time management, project management, delegation, multitasking, decision-making and problem-solving skills.
Excellent attention to detail and commitment to quality.
Able to project and maintain professionalism in handling difficult situations and in times of stress.
Flexibility to adapt and meet fluctuating business priorities.
Must be willing to travel at least 5%, including internationally.
Fluent in English speaking and writing.
University/Bachelor’s degree and/or appropriate relevant work experience.
5 years’ Quality experience in pharmaceutical or medical device industries or other regulated industries (i.e., healthcare).
A minimum of 2 years’ experience hosting GCP audits required.

Nice To Haves

Prior Clinical Research Organization experience is preferred.

Responsibilities

Host and/or Support CRS/FSP client audit and/or regulatory authority inspection (audits/inspections) activities including but not limited to audit/inspection preparation, conduct, reporting, serve as SME for applicable quality topics, CAPA review/approval/ completion, and eQMS record management activities.
Develop responses to CAPAs arising from client/inspections, as applicable to CQA, and tracks to completion and closure.
Collaborate with multiple lines of business to prepare for/conduct audits/inspections.
Coordinate Client Questionnaire Audits and serve as SME for applicable quality topics
Perform review and approval of Deviations, Quality Events, CAPAs, and Effectiveness Checks in the eQMS.
Support CRS/FSP project leadership in setup and subscription of Client and/or project-specific Deviation, Quality Event, and CAPA eQMS reports for Client provision, as contractually obligated.
Conduct periodic review of Deviation, Quality Event, and CAPA eQMS reports to facilitate identification of emerging trends.
Escalate emerging trends to Management for improvement opportunities.
Perform GxP change management activities including risk and impact analysis review, change plan review and approval, action implementation to completion, and eQMS record management.
Provide ongoing GxP Subject Matter Expertise (SME) to CRS/FSP staff including but not limited to consulting on regulatory requirements and guidance and components of the ProPharma QMS.
Participate in CRS/FSP Client operational meetings requiring CQA representation.
Contribute to the creation of controlled documents such as SOPs and Work Instructions.
Perform quality review and approval of CRS/FSP and/or Quality Assurance controlled documents.
Collaborate in the review and approval of CRS/FSP computerized systems related validation documentation in the eQMS.
Identify any issues which could potentially impact services and escalates any areas of concern within the business to Management, with potential corrective actions.
Support the delivery of the internal quality program including quality assurance and quality control.
Maintain awareness of and ensure adherence to applicable SOPs/ controlled documents, applicable GxP regulations, and client agreements.
Perform other duties as required.