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Overview

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Every day we perform better because of how we work together, as one team, each the best at what we do. We bring together talented experts across a broad spectrum of business critical corporate functions. Every role plays an essential part in enabling our customers to achieve their goals. Our teams are agile, collaborative, and committed to delivering—for each other, for our customers, and ultimately for the people who rely on the services we support.

Job Title and Reporting

Job Title: Associate Director, Corporate Quality Relationships

Reports to: Director/Senior Director, Corporate Quality Relationships

JOB SUMMARY

Partners with our internal and external customers, providing expert quality support based on a deep understanding of current global Good Clinical Practice (GCP)/GxP requirements and regulatory expectations with the ultimate goal of improved quality and increased customer satisfaction. May develop, manage and support a team to create a Quality to Quality interface across accounts, providing each relationship with a single point of contact for quality related matters.

JOB RESPONSIBILITIES

General Profile

- Provides quality oversight, support and consultancy for or within accounts, as assigned
- Supports the internal account and/or operational teams on quality delivery and continuous improvement
- Provides quality consultancy and support for project/program/functional/account level quality issues, audits, and inspections (e.g. support for audit/inspection preparation and response activities and inspection readiness activities)
- Partners with the responsible person for account management (or key project/account team members) and the customer Quality representative to develop and execute a Quality Management Plan/Quality Agreement that will meet the needs of the customer, if applicable
- Performs complex conceptual analyses to evaluate the state of the quality of the complex projects/program/function or account using key quality metrics and/or KPIs




- Investigates quality trends, potential risks and mitigations with key project/program/function and account team members
- Presents information to key stakeholders and the customer Quality representative, as applicable

- May have direct management and accountability for CQR Professionals. Manage performance and remediate performance issues. Foster growth and development of direct reports to ensure compliance with policy, procedure and regulatory requirements. Supports direct reports related to goal setting, problem resolution and decision making. Recruit, interview and hire new CQR staff. Participate in CQR SOP/procedure development, training and implementation. Participate and/or develop key departmental initiatives

Functional and Technical Expertise

- Requires depth and/or breadth of expertise within discipline and recognized in a function or geographic region
- Provides explanations and information to others on difficult issues
- Acts as a resource for others with less experience
- May coach, provide feedback, and guide others
- Requires supervisory skills and sufficient GxP/regulatory/technical/process and business knowledge to provide support to direct reports (as applicable)

Complexity

- Solves complex problems and/or conducts complex analyses and translates concepts into practice
- Identifies and supports resolution of departmental problems including issues outside the immediate team (as applicable)
- Decision Making – makes decisions that impact the function or geography; may impact direct reports based on knowledge and experience
- Influence – influences regulatory, business, or technical issues within a function; serves as a primary resource to direct reports
- Problem Solving – anticipates and resolves key technical, operational, or business problems; applies strategic thinking to non-standard requests
- Impact – drives solutions for resources, assignments and performance




- Customer/External Focus – builds relationships with internal and external customers and partners; interacts with regulators and customers on business issues
- Project Management – leads and manages quality-focused project/account initiatives
- Accountability and Scope – accountable for performance of direct reports
- Financial and Resource Management – forecasts resource needs and manages allocated budget (as applicable)
- Strategic Planning – develops plans to meet short-term objectives

Supervision

- Works with minimal guidance; may manage CQR Professionals and Manager, CQR

Other tasks

- Perform other quality-related activities as documented in the Quality Relationship Plan / Quality Agreement and as agreed with the client
- Represent Corporate Quality Relationships, as assigned
- Travel may be required (approximately 25%)
- This position is client facing and may be responsible for managing employees

QUALIFICATION REQUIREMENTS

University degree and professional experience or equivalent. Experience in global clinical research, pharmaceutical, or biotechnology company preferred. Thorough knowledge of drug development and ICH GCP Guidelines is necessary. Experience in quality management and/or process improvement is essential. Comfortable working closely with customers. Effective critical thinking, conflict resolution, strategic planning, communication, written and analytical skills. Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail. Experience working in a matrix team environment is preferred.

Disclaimer :

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks and responsibilities. Equal or equivalent experience will be considered. The Company will determine what constitutes equivalence to the qualifications described. This job description does not create an employment contract. The content complies with applicable laws and disability accommodations where appropriate.

Get to know Syneos Health

Over the past 5 years, we have worked with many products and studies across a general network. This is a client-facing role in a dynamic, collaborative environment.

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Postúlate en Kit Empleo: kitempleo.com.ar/empleo/pwxri

📌 Associate Director, Corporate Quality Relationships (Buenos Aires)
🏢 Syneos Health
📍 Buenos Aires