Manager, Commercial Quality Excellence

at  Syneos Health Commercial Solutions

JOB SUMMARY

The Manager, Commercial Quality Excellence (Argentina) is an experienced quality manager in the life sciences and/or healthcare industry who has responsibility for supporting the development and continuous improvement of an effective Quality Management System (QMS) for the Commercial division of the organization. They are a strategic partner for the Commercial division and take ownership of important quality initiatives as defined by the Sr. Director, Commercial Quality Excellence (US), provide quality support and guidance to various Commercial business units and customer account management teams, continually seek to identify areas for process improvement opportunity, embody quality culture, and lead cross-functional teams in the design and implementation of internal processes and strategies that will optimize business outcomes and meet customer-specific requirements while ensuring alignment with the Syneos Health Quality Manual and regulatory requirements.

QUALIFICATION REQUIREMENTS

• Education and Experience:
• Bachelor’s degree, or equivalent combination of education, training, and experience.
• 8+ years professional work experience in the health sciences or life sciences industry, with 5+ years of experience in a quality or compliance related field required.
• 3+ years of experience in a management role with key decision-making responsibilities highly preferred
• General knowledge of current Good Manufacturing Practices (GMPs), Post-Marketing Good Pharmacovigilance Practices (GVP), Data Integrity standards, and other applicable regulations.
• General knowledge of interpreting and applying regulatory requirements for drug product Risk Management Programs (RMP) and/or Risk Evaluation and Mitigation Strategy (REMS) and/or working on a RPM or REMS program is a plus.
• Experience with designing and implementing processes that streamline operations in a highly matrixed environment to reduce redundancies, improve efficiency, and produce quality outputs.
• Experience authoring SOPs, work instructions, job aids, forms, and associated training presentations.
• Experience with customer and internal audit preparation and support, and ensuring ongoing audit/inspection readiness; Experience supporting regulatory inspections a plus
• Experience performing complex root cause analysis and developing robust CAPA plans.
• Experience tracking and trending quality data/metrics, developing reporting, and interpreting data to make decisions and recommendations to department leaders and internal stakeholders for risk remediations and process improvements.
• Experience with successful interactions and influence with various levels of stakeholders to motivate staff in a matrix structure to support company objectives, meet deadlines, and deliver high quality work in a dynamic environment.
• Experience with driving quality culture and change management across functions and departments.
• Knowledge of ISO 9001 QMS standards a plus.
• TrackWise QMS software experience a plus.
• Skills:
• Advanced level proficiency in English language, verbal and written.
• Reliable, responsible self-starter who works well independently and demonstrates solid decision-making abilities.
• Highly organized with a keen eye for detail, accuracy, and quality product.
• Above average organizational, interpersonal, and team-oriented skills with strong professional acumen when interacting with internal and external customers.
• Ability to perform several tasks simultaneously to meet deadlines.
• Flexible, enthusiastic, highly adaptable, quick to assimilate new information, and demonstrates initiative as a team member and leader.
• Demonstrates understanding of the workflow process, roles, and responsibilities of multiple functional areas.
• Excellent written and verbal communication, presentation, and analytical skills.
• Ability to conduct and effectively facilitate meetings, i.e., audit preparation, quality initiatives/issues resolution working sessions, and presentations to internal stakeholders.
• Ability to simplify dry/complex concepts.
• Practical real-world approach and business savvy.
• Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Teams) and SharePoint. Willingness to embrace new technologies.
• Other Requirements:
• Fully remote in Argentina
• Willingness to travel/commute (< 5%) to the Buenos Aires, Argentina office for company meetings and events when requested.
• Must have valid, current driver’s license and passport, as well as the ability to secure corporate credit card. Ability to comprehensively manage periodic commute/travel to the Buenos Aires, Argentina office for company meetings and events as requested.
  At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.
  Why Syneos Health? We partner with industry experts to solve and execute against today’s toughest commercialization challenges facing the world’s leading healthcare companies. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities on our Commercial Operations and Leadership teams. Join our game-changing, global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients’ lives around the world.
  Work Here Matters Everywhere | How are you inspired to change lives?
  Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)
  Syneos Health has a voluntary COVID-19 vaccination policy. We strongly encourage all employees to be fully vaccinated. Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees. These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements.
  At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position will include a competitive compensation package, Health benefits to include Medical, Dental and Vision, Company match 401k, flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos Health complies with all applicable federal, state, and municipal paid sick time requirements

• Assists the Sr. Director/Director, Commercial Quality Excellence (US) in the development, implementation, and continuous improvement of the Commercial division’s Quality Management System (QMS) with the primary goal of ensuring business processes meet the highest standards of quality, comply with applicable regulatory guidelines, and adhere to contractual customer requirements.
• Collaborates and consults with the Corporate Quality (CQ) department that provides independent oversight, guidance, and consultancy for development of the QMS, performs internal audits, and hosts customer audits and regulatory inspections.
• Serves as a Commercial Quality subject matter expert, challenges the status quo, supports change management, and promotes a positive quality culture within the organization.
• Drives QMS implementation and process improvement initiatives by leading the activities of cross-functional teams in planning and operationalizing new or revised processes, ensuring timelines and milestones are met, and escalating obstacles or risks to the Sr. Director/Director, Commercial Quality Excellence (US).
• Addresses Commercial business risks/issues and quality non-conformances by performing root cause analysis, tracking/trending to identify systemic issues, providing guidance to responsible parties on appropriate remediation activities, and monitoring the status of remediation plans. May be assigned to lead remediation plans as applicable.
• Reviews internal processes and documentation to verify they meet Syneos, customer and regulatory requirements, monitors KQIs/KPIs, facilitates action when metrics fall out of targeted range and escalates risks to the Sr. Director/Director, Commercial Quality Excellence (US).
• Proactively seeks out opportunities for process improvements and/or new processes and makes recommendations to the Sr. Director/Director, Commercial Quality Excellence (US) for future Commercial Quality initiatives.
• Supports the Commercial division through all stages of audits (customer, internal and regulatory) including audit preparation activities, tracking, and reviewing audit requests, and supporting responsible parties with finding responses, root cause analysis and CAPA plan development. Tracks status of open CAPAs and may also be assigned as a CAPA owner when applicable.
• Performs functions of the TrackWise System record owner for Commercial Audit CAPA and Quality Issue Action records.
• Authors job aids, operational guides, and Controlled Documents (CDs) for CQE functional area and performs quality review of CDs drafted by Commercial CD authors. Verifies drafted CDs meet applicable policies, regulatory standards, plans/specifications, and customer requirements/expectations. Where applicable, ensures appropriate internal communication and training on CDs and supports activities to operationalize documented procedures within the business as required.
• Supports Sr. Director/Director, Commercial Quality Excellence (US) with development of departmental processes within CQE, provides staff training, and delegates work to team staff.
• Serves on CQE’s Functional Training Council (FTC) to provide input and decisions on essential required functional area (a.k.a. department) training and may serve as a temporary Functional Training Liaison (FTL) to support a Commercial business unit(s) that is in-process of establishing their FTL and FTC structure.
• Promotes adherence to internal process and contractual customer obligations, and appropriately escalates issues or concerns to the Sr. Director/Director, Commercial Quality Excellence (US).
• Works with Commercial division to find practical solutions to issues and process inefficiencies, and verifies remedies are completed in a timely manner to the project specifications.
• Performs other work-related duties as assigned.