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We know just how important it is to put people first. It's with that human touch that we've played a part in nearly all of the top 50 treatments on the market. And every day, we're focused on working with industry leaders to bring life-changing healthcare to patients across the globe. Whether you join our Clinical, Consulting, Biotech, Functional Service Provider (FSP), or other teams, we're doing it With Heart ™.

Manager, Quality

Job ID R0000002189 Baltimore, Maryland, United States of America

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Baltimore, MD (On-site)

Provide leadership and management to other Project Quality & Risk Management staff. Innovate and 
implement quality improvement opportunities at the project, client, operational, department or cross department level.

Collaborate with senior leadership to implement strategy and direction for PQRM staff. 

  • Work with direct reports to establish individual contributions to achieving departmental goals. 
  • Support PQRM staff in achievement of individual and collective goals 

Contribute to and support PQRM specific risk management utilizing all available tools / dashboards.

  • Work with PQRM leaders to identify, categorize, score and develop mitigations 
  • Confirm agreed mitigations are being integrated into departmental planning 
  • Coordinate and support leaders in regular risk review 
  • Assess effectiveness of mitigations with leaders 
  • Promote and support documenting lessons learned 

Oversee and support PQRM staff to comply with Parexel standards and regulatory requirements. 

  • Verify compliance with Parexel SOPs and other requirements (e.g. applicable curricula) 
  • Review, approve (when necessary) and ensure accurate time recording for direct reports (e.g. billing out of department etc.) 
  • Provide guidance and ensure compliance with goal setting and PDC requirements 
  • Serve as subject matter expert (SME) for Risk Management Process as assigned 

Partner with Quality Assurance to oversee and support audits & inspections, representing Parexel Quality when requested and serving as an escalation point for critical issues.

  • Support audit/inspection preparation including coordinating with QA and PQRM regional leadership. 
  • Identify and assign resource
  • Provide onsite or remote support as needed 
  • Represent PQRM in audits and/or inspections 
  • Contribute to critical issue resolution by providing expert quality advice and direction 
  • Host audits as assigned per role (e.g. EP)​ 

Provide solutions-focused quality consulting. 

  • Support direct reports with project-level escalations 

  • Review of planned SOP deviations as assigned 
  • Escalate issues to PQRM Senior Leadership as necessary 

Develop and cultivate transparent quality relationships, while managing expectations with client quality representatives, including when needed fulfilling the role of Portfolio Quality and 
Risk Lead or Quality Sponsor. 

  • Represent Parexel Quality in client meetings as necessary 
  • Serve as the point-of-contact for the client quality representatives as assigned 
  • Lead quality-to-quality meetings as needed 
  • As Portfolio Quality and Risk, perform client-level risk and issue management 
  • As Portfolio Quality and Risk, provide client-level quality oversight serving as a point of escalation, communicating pertinent information to account leadership as necessary 
  • As Portfolio Quality and Risk, develop/revise quality agreement as necessary 
  • As Quality Sponsor, serve as senior-level point-of escalation, communicating with senior client quality partners 

Attract, recruit, retain and develop PQRM staff. 

  • Engage and recruit qualified staff 
  • Ensure staff is trained and supported 
  • Contribute to employee pipeline 
  • Measure direct reports’ performance against expectations and standards, providing constructive feedback with strengths and areas for improvement, focusing on development of individual employees 

Identify areas for continuous improvement of the Quality Management System by submitting feedback on processes, participating in process improvement initiatives as requested. 

  • Provide feedback via the appropriate channel when gaps or issues are identified with Parexel processes. 
  • Propose ideas to Parexel Quality leadership related to departmental efficiencies, potential improvements, or innovations. 
  • Contribute to and participate in the Quality Forums and Quality Review Board (QRB) as requested.

Maintain compliance with Parexel standards. 

  • Comply with required training curricula 
  • Accurately complete timesheet as required 
  • Submit expense reports as required by SOP 
  • Update CVs as required by SOP 
  • Comply with Parexel processes, ICH-GCPs and other applicable requirements

Mentor PQRM Leaders as needed. Mentor PQRLs and EP Quality Specialists as assigned. 

  • Serve as an integration partner to facilitate induction to PQRM leadership. Establish formal, documented plan for each new hire assigned. Design and provide training for PQRM as assigned. 
  • Provide feedback to line management on progress.

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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