Sr. Manager, Commercial Quality Excellence – Risk Management & REMS

Description

The Sr. Manager, Commercial Quality Excellence- Risk Management & REMS (“RM & REMS”) 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 take ownership of important quality initiatives, 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. The Sr. Manager, Commercial Quality Excellence- RM & REMS is the fully-dedicated lead Commercial Quality Partner for the Risk Management (RM) and Risk Evaluation and Mitigation Strategy (REMS) business teams, managing and overseeing the RM & REMS quality program, including spearheading efforts for the business teams’ specific needs and objectives for continuous quality improvement, operational excellence, and audit/inspection readiness. The Sr. Manager, Commercial Quality Excellence- RM & REMS is also responsible for supervision, management, and development of direct reports within the Commercial Quality Excellence (CQE) team.

Job Responsibilities

• Commercial Quality Excellence:
• Assists the Sr. Director/Director, Commercial Quality Excellence 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.
• Serves as a Commercial Quality representative and subject matter expert, challenges the status quo, supports change management, and promotes a positive quality culture within the organization.
• Manages 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, Commercial Quality Excellence.
• 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, Commercial Quality Excellence.
• Proactively seeks out opportunities for process improvements and/or new processes and makes recommendations to the Sr. Director, Commercial Quality Excellence for future Commercial Quality initiatives.
• Promotes adherence to internal process and contractual customer obligations, and appropriately escalates issues or concerns to the Sr. Director, Commercial Quality Excellence.
• Risk Management and Risk Evaluation and Mitigation Strategy (“RM and REMS”) Quality:
• Serves as the fully-dedicated lead Commercial Quality Partner for Risk Management and REMS business teams, including Full-Service REMS programs and Consulting Risk and Program Management (RPM) Advisory Group programs.
• Spearheads efforts to support the Commercial RM and REMS business teams’ needs and objectives for management and ongoing improvement of the RM and REMS quality program, recommends options to drive continuous process improvements and audit/inspection readiness, and ensures alignment of the RM and REMS quality program with the overarching standards of the Syneos Health QMS.
• Organizes RM and REMS internal process audits conducted by Corporate Quality’s QA group, including identifying internal process audits necessary for risk management and ensuring audit/inspection readiness.
• Assists with RM and REMS vendor qualification audits as a Subject Matter Expert (SME) and document reviewer to support the Syneos Health Corporate Quality QA auditor, as needed.
• Leads and guides the Commercial RM and REMS business areas through all stages of audits and inspections (sponsor, internal and regulatory) including audit preparation activities, addressing auditor questions and requests specific to the RM and REMS quality program, tracking, and reviewing audit requests, and supporting responsible parties with finding root cause analysis (RCA), Corrective Action Preventive Actions (CAPAs) and Effectiveness Checks development. Tracks status of open CAPAs and Effectiveness Checks and may also be an action owner when applicable.
• Provides SME advice and support to the RM and REMS business teams’ Controlled Document (CD) Liaisons and Authors and conducts a formal review of authors’ drafted CDs (i.e., SOPs, Work Instructions, Forms, Templates).
• Maintains the RM and REMS Quality ontology model which codes internal and external stakeholder deviations, non-compliance, issues, failures, etc. and drives integration across all relevant RM and REMS activities.
• Maintains the failure investigation process across the RM and REMS business teams, advises teams regarding RCA and proposed CAPAs, analyzes failure investigation data, and recommends options to drive continuous improvement.
• Works with RM and REMS business leaders to explain the critical nature of the RM and REMS quality program to their teams and helps drive a quality culture.
• Coaches and trains RM and REMS business teams in quality-related matters and provides consultancy regarding quality and regulatory questions.
• Supports the Sr. Director, Risk Management and REMS, as needed and requested, with developing quality-related responses for pre-award Requests for Proposals (RFPs)/Requests for Information (RFIs) and post-award routine RFIs (i.e., sponsor due diligence quality RFIs/questionnaires).
• Supports the Sr. Director, Risk Management and REMS, as needed and requested, in review of RM and REMS vendor and sponsor contracts and technical quality agreements, specifically verbiage for quality requirements and expectations, and seeks consultation from Corporate Quality as applicable.
• Establishes RM and REMS quality and audit/inspection metrics and provides periodic updates to RM and REMS business area leadership during governance meetings.
• Other:
• Directly responsible for supervision, management, and development of direct reports, ensuring optimal allocation of resources for coverage of work and objectives.
• Performs other work-related duties as assigned.
  

Qualification Requirements

• Education and Experience:
• Bachelor’s degree in a science/healthcare field, or equivalent combination of education, training, and experience required.
• 8+ years professional work experience in the health sciences or life sciences industry, with 5+ years of experience in a quality management or compliance related field required.
• 4+ years of experience in a management role with key decision-making responsibilities and oversight of direct reports required.
• Knowledge of interpreting and applying REMS regulatory requirements highly preferred.
• Previous experience working on a REMS program preferred.
• Working knowledge of current Good Manufacturing Practices (GMPs), Post-Marketing Good Pharmacovigilance Practices (GVP), Data Integrity standards, and other applicable regulations.
• Experience with developing and implementing complex initiatives and processes in a highly matrixed environment in order to comply with regulations, reduce redundancies and risks, improve efficiency, and ensure ongoing process improvements to produce quality outputs.
• Experience with customer and internal audit preparation and support, and ensuring ongoing audit/inspection readiness; Experience supporting vendor audits and regulatory inspections is a plus.
• Experience performing complex root cause analysis and developing robust CAPA plans.
• Experience authoring SOPs, work instructions, job aids, forms, and associated training presentations.
• Experience tracking and trending quality data/metrics, developing reporting, and interpreting data to make decisions and recommendations to leadership and internal customers for risk remediations and process improvements.
• Experience with driving quality culture and change management across functions and departments.
• 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.
• Knowledge of ISO 9001 QMS standards a plus.
• TrackWise QMS software experience a plus.
• Skills:
• Reliable, responsible self-starter who works well independently and demonstrates excellent 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 lead effective lead meetings, working sessions and presentations to leadership.
• Ability to simplify dry/complex concepts.
• Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Teams) and SharePoint. Willingness to embrace new technologies.
• Other Requirements:
• Fully remote in US
• Willingness to travel (~ 10%) to Bridgewater, NJ and Newtown, PA offices for onsite department meetings, company events, and audits/inspections 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 required travel.
  

The annual base salary for this position ranges from $119,000 to $139,000. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. In addition, some positions may include eligibility to earn commissions/bonus based on company and / or individual performance.

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.

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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.