Quality Ppdm Process Management Lead

**Job Summary**

The** Quality PPDM Process Management Lead** manages the Clinical Medical Controlled document (CMCD) process and procedural document portal (relational database that includes business process modeling and allows for management of controlled documents and associated information with an end user interface which provides the business access to internal sponsor's colleagues, auditors, vendors, and regulatory authority inspectors), structure, content, quality and core and end user implementation from a global and local country & functional area perspective. The responsibilities include overseeing and performing quality checks for all processes and associated content and documentation for consistency and standards and assisting process documentation designer with development, revision, maintenance and oversight of specific activities, such as mapping process flows and associated content. This job also leads the development of departmental metrics and other reporting activities; facilitates/contributes to the process evaluation and integration of acquired company and/or asset related programs into sponsor's processes; contributes to compliance and audit/inspection readiness strategies and plans; and is responsible for ensuring high quality execution of controlled procedural documentation management used for the conduct of business in clinical, medical, regulatory, safety and quality assurance organizations in compliance with regulations, laws, company policy and best practices.

**Responsibilities**:

- Accountable to manage and implement the quality oversight plan for the process portal content containing ~ 42,000 informational objects pertaining to process quality standards, global and local country & functional area procedural documentation (policies, SOPs and associated documents) and other related information to ensure ongoing availability of complete and accurate process and procedural document content for clinical, medical, safety, regulatory and enterprise quality management system processes. It is essential that this content remain accurate and up to date as it is included in Pharmacovigilance regulatory submissions.
- Interpret business challenges and best practices to deliver strategic recommendations regarding process portal design and implementation; propose options to resolve complex problems and make decisions within business line.
- Lead/support development and ongoing evaluation of departmental processes, providing advice on process enhancements, continuous improvement and project management.
- Manage to resolution any questions about or issues arising from the Process portal, process modeling or standards and conventions.
- Oversee support staff and contingent workers in daily activities related to the process portal, including training on process enhancements, and providing feedback and remediation
- Enter and maintain data/information into the CMCD process and procedural document portal by collaborating with the CMCD authors
- Independently manage the S&T query assistant website business process and content of over 1200 questions/answers
- Lead special projects related to process portal as requested by supervisor

**Departmental Metrics**
- Independently prepare monthly/biannual/annual metrics, identify and evaluate metric trends
- Lead the review, endorsement, issue follow-up/resolution, and communication of metrics.

**Controlled Procedural Documentation Management**
- Oversee the activities of procedural document compliance staff
- Maintain consistent workflow, prioritize needs, and establish coverage
- Provide coaching and guidance to staff members
- Review work of staff members as needed
- Keep staff members up-to-date on internal processes
- Manage resolution to queries
- Manage projects pertinent to the role
- Perform quality control checks for globally managed procedural documents by following internal processes and established standards within agreed timelines
- Support documentation life cycle within the Global Document Management System (GDMS) to maintain a state of inspection readiness

**Process Evaluation/Integration & Acquisition**
- Facilitate/contribute to the evaluation of regulations, acquired procedures, etc. into processes ensuring proper compliance, documentation, and implementation plans

**Audit/Inspection Readiness & Support**
- Facilitate/oversee the accuracy and completeness of process portal data by evaluating queries, performing data reviews, and reconciling findings to ensure accurate reporting
- Contribute to compliance and inspection/audit readiness strategies and plans
- Participate in regulatory inspections, and other internal/external audit requests, quality control checking and providing information, and responding to findings

**Qualifications/Skills**

**Basic Qualifications**:

- A scientific or technical degree is preferred.
- Business degree and/or coursework with specific training in the following is preferred:

- process modeling, desi