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Senior Manager, Commercial Quality Excellence
2 months ago
We are seeking a highly experienced and skilled Senior Manager, Commercial Quality Excellence to join our team at Syneos Health/inVentiv Health Commercial LLC. This role will be responsible for leading the development and implementation of an effective Quality Management System (QMS) for the Commercial division, ensuring business processes meet the highest standards of quality, comply with applicable regulatory guidelines, and adhere to contractual customer requirements.
Key Responsibilities- Commercial Quality Excellence:
- Assist the Sr. Director/Director, Commercial Quality Excellence in the development, implementation, and continuous improvement of the Commercial division's QMS.
- Serve as a Commercial Quality representative and subject matter expert, challenging the status quo, supporting change management, and promoting a positive quality culture within the organization.
- Manage QMS implementation and process improvement initiatives by leading cross-functional teams in planning and operationalizing new or revised processes.
- Review internal processes and documentation to verify they meet Syneos, customer, and regulatory requirements, monitor KQIs/KPIs, and facilitate action when metrics fall out of targeted range.
- Proactively seek out opportunities for process improvements and/or new processes and make recommendations to the Sr. Director, Commercial Quality Excellence.
- Risk Management and Quality Assurance:
- Serve 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.
- Spearhead 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.
- Organize 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.
- Assist 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.
- Leadership and Development:
- Directly responsible for supervision, management, and development of direct reports, ensuring optimal allocation of resources for coverage of work and objectives.
- Perform other work-related duties as assigned.
- 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.
- 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.
We offer a competitive compensation package, including a base salary range of $119,000 to $139,000, as well as opportunities for professional growth and development. We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and experienced professional looking to join a dynamic team, please submit your application.
