The primary function of the Quality Program Manager is to provide the Patient Outreach organization with direction and strategic leadership in quality matters and to ensure compliance with appropriate standards. This position will also be responsible with the oversight of partner vendors to ensure quality processes are in place, documented, and being followed in the execution of 4 major contracts totaling $80M dollars.
This position requires the ability to evaluate program interdependencies as well as coordination with key stakeholders in teams such as OEC, legal, Sales, Marketing, Public Affairs and other home office stakeholders.
Responsible for implementing and maintaining the effectiveness of the quality system by:
- Adheres to Abbvie corporate, divisional and departmental Operating Procedures and guidelines.
- Acts as the primary quality lead for projects and teams to achieve on-time quality deliverables, high customer value, and profitable results.
- Establishment and maintenance of metrics reporting, monitoring, business/management reviews, and project management (internal and vendor focused)
- Policies & Procedures:
- Develop, manage and implement AbbVie standardized policies, procedures and work instructions which provide direction to multiple vendors.
- Address quality gaps to help drive consistency and compliance.
- Recommend continuous improvement initiatives and procedures.
- Manage the document change control process to ensure compliance.
- Responsible for holding personnel and functional areas to these policies to promote adherence and the development of Corrective Action Preventative Action (CAPA) plans for areas of noncompliance.
- Quality Assurance:
- Ability to identify problems then initiate corrective actions and preventative action plans.
- Determine strategy, implement/deploy, maintain, and oversee continuous quality improvement.
- Assess the adequacy and effectiveness of the quality system by conducting or directing internal audits, compliance reviews and quality assessments.
- Assists OEC on the development, execution, and tracking of OEC monitoring or training needed for the ambassador or advocate programs.
- Develop and implement compliance programs as needed as the organization evolves and industry practices and regulations change.
- Responsible for ensuring adequate compliance processes are developed, deployed and maintained through performing impact analysis.
- Manage audit/inspection preparedness, response and compliance aspects. Host internal and external audits/inspections. Conduct or direct internal compliance audits and lead/develop Corrective Action Preventative Action (CAPA) plans for noncompliance.
- Drive strategic plans for business quality systems with an alignment of projects with company vision and culture.
- Interface with all levels of management and multiple functions. Develop performance reports and presents to senior level leadership (VP/GM). Must be seen as a leader, trusted to advise and recommend policies, strategies, and solution for supplier quality management.
Reporting to the Patient Outreach Project Director, Patient Outreach Services, this manager will drive Quality planning, and implementation for critical activities that focus on Field Patient Outreach Services and Nursing Services.
The role must effectively establish and maintain credibility and influence key stakeholders; the incumbent must handle very sensitive information with strict confidence and professionalism.
B.A./B.S./Business, Communications, Marketing or related field (MBA not required, but desirable)
Knowledge of applicable regulations and standards affecting Pharmaceutical Products (e.g. CFR 210/211, cGMP) specifically,
Proven experience in Quality, OEC, or legal area of policy and procedures
2+ years of experience in pharmaceutical industry or related field.
Strong writing skills, procedural or technical writing
Proven leadership competencies to include setting vision and strategy, building teams, knowing the business, driving for results, and encouraging open exchange of ideas and knowledge.
Strong, proven experience across multiple functions including customer service in fast-paced, service/team environment (call center, customer service, marketing services)
Customer database management and customer relationship management
A highly motivated change agent that drives business-focused solutions.
Strong written, verbal and presentation skills with the ability to distill highly complex requirements into compelling business objectives.
Strong problem solving abilities in complex, compliance regulated department.
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AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories.Together with its…
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