Key Facts

Remote From:

Full time

Senior (5-10 years)

English

Hard Skills

Root Cause Analysis Auditing Data Management Regulatory Compliance Business Process Improvement Process Management Regulatory Compliance Project Management Good Documentation Practices Quality Assessment Due Diligence DOT (Department Of Transportation) Inspections Care Management Process Analysis Auditing Executive Conversations Clinical Trial Planning Lean Methodologies Stakeholder Communications

Other Skills

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Technical Acumen
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Team Leadership
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Organizational Skills
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Mentorship
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Verbal Communication Skills

Roles & Responsibilities

BS degree with 10+ years of experience or an MS/MBA with 9+ years of experience (or equivalent)
Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP/GxP Quality and/or regulatory
Regulatory inspection experience
Strong knowledge of GCP requirements and applicable SOPs/regulations, plus project management, administrative, and verbal/written communication skills; Lean Six Sigma/continuous improvement background preferred

Requirements:

Manage confirmed Quality Event investigations (Major/Critical QE) ensuring timely timelines, robust root cause analysis, and compliant documentation; oversee QA review of select QE cases and drive process improvements
Coordinate audits and inspections for GCP processes and CRO/vendor audits; manage CAPA and support inspection readiness and sponsor inspections; communicate progress to stakeholders
Mentor and train Issue Leads to ensure proper assessment, categorization, and qualification of submitted Quality Events
Lead QE-related process improvements and participate in special projects to enhance case management and quality systems

Parexel

Pharmaceuticals

About Parexel

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

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Job description

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.

Parexel is looking for multiple Senior Issue Leads to join our team. The candidates can be based anywhere in Argentina, Mexico or Brazil!

The Senior Issue Lead will be accountable for

· Quality Events: managing confirmed Major / Critical Quality Event (QE) cases through the investigation process including root cause analysis. The Senior Issue Lead will ensure the investigations are conducted thoroughly, within required timelines and to compliance requirements including ensuring the adequacy of root cause analysis and appropriateness of communication regarding the case. The Senior Issue Management Lead will direct the QE team in proposing appropriate Corrective and Preventative Actions and that completion of all those are evidenced in documentation as required. The Senior Issue Lead will be assigned to and manage Critical and other complex cases and especially those that require presentation to senior leaders as part of the Quality Review Team (QRT)

· Audits and Inspection Coordination: Drive GCP quality in withstanding regulatory scrutiny, operational data and documentation. Major areas of focus will include:

o Audit coordination for GCP related process and preferred CRO vendor audits

o CAPA management

Directing Inspection readiness and providing inspection support for GCP sponsor inspection activities

Role Responsibilities

Quality Event Investigation

The Senior Issue Lead will ensure that each confirmed case is investigated appropriately including ensuring investigation timelines are met and that appropriate pre-work is done on the case to enable a meaningful investigation with appropriate quality outcomes which includes a case summary which meets defined quality standards and can be used for a regulatory inspection. The Senior Issue Lead will perform quality review and approval of select quality events which have been managed by other investigation leads. He/she will be assigned to process improvement initiatives and special projects as necessary and be expected to drive changes to the business process for case management when the need arises.

Training and Technology

This individual will also be required to mentor and train Issue Leads to ensure the individuals reviewing the submitted issues are qualified to assess and categorize the submitted Quality Events.

Audit and Inspection Coordination

This individual may be assigned additional focus areas in audit coordination or inspection coordination, including inspection responsibilities around:

Directing asset/study team colleagues within CD&O/Clinical to ensure successful inspection and audit outcomes
Communicating audit and inspection progress and needs to CS&O/Clinical stakeholders
Serving as the point of contact for Regulatory Quality Assurance related to audit and inspection CAPA management

Quality Compliance Assessment

Plan, lead and report out on Quality and Compliance Assessments related to CD&O processes

Root Cause Analysis

This individual will also be required to apply a root cause methodology and/or due diligence approach to assigned QEs. This individual may either lead QE cases from start to finish

Requirements:

BS – 10+ years or equivalent

MS/MBA – 9+ years or equivalent

Previous Experience:

Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory
Regulatory inspection experience
Process and system management experience
Detailed knowledge of clinical trial processes and relationships required
Knowledge of GCP requirements and applicable SOPs and regulations
Project management, administrative, and technical capabilities are required, as well as effective verbal and written communication skills
Strong background in continuous improvement methodology (i.e., Lean Six Sigma) preferred