Sr/compliance Manager

hace 3 meses

Madrid, España Thermo Fisher Scientific A tiempo completo

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

Our colleagues in quality strive for excellence in every task, at every moment. We are game changers seeking improvements to processes and more efficient ways of working or adapting to changing financial and industry environments.

As a Senior Compliance Manager for Real World Data Solutions (RWDS), you will revamp a Quality System to include Real World Evidence guidance and direction, encompass and measure data quality and data integrity and customer satisfaction in the real world data and real world evidence space, and oversee the quality function of the RWDS group to include managing quality events, planned deviations, procedural documents and external audits.

**Summarized Purpose**:
Provides strategic direction and management of a real world data specific quality management system program. Where and when role requires, incumbent provides oversight to auditing techniques, quality management training, interpretation of regulations and guidelines, technology best practice as well as computer validation and compliance. Assists business development and senior management in securing new business via request for proposal support. Develops and supports effective solutions, using proven problem solving techniques, to address nonconformance issues with existing clients. This will include responsibilities in supporting quality systems and investigations or deviations and the corrective and preventive (CAPA) action plans. Participates in training activities which will include generating training and delivery.

**Essential Functions**:

- Develops and executes RWDS quality planning, assurance, control, record retention, corrective and preventive action process and process improvement initiatives ensuring these quality assurance and quality control measures are in line with and comply with the existing applicable CRG processes and procedures
- Assists with the creation, maintenance and compliance with procedural documents (e.g., standard operating procedures (SOPS), job aids, etc.)
- Identifies and collaborates with peers in QA and within RWDS to proactively identify issues impacting quality, determines root cause of nonconformance, and develops effective problem solution strategies
- Analyzes compliance/quality matrix data and notifies senior management of critical compliance nonconformance
- Leads process/quality improvement initiatives and serves as project lead for department quality initiatives
- Provide support for client audits
- Leads quality and compliance processes and engages with a variety of cross-departmental staff to ensure appropriate execution and completion (e.g., quality events, planned deviations, inspections and audits, procedural documents, vendor oversight)
- Develops and effectively shares guidance and reference information, repositories, and communication channels (e.g., requests for information/ proposals (RFI/RFP), policies, procedures, guidance documents, quality management systems training)
- Assists in business development activities to obtain additional contracts by providing input to the proposal process and making presentations to potential clients
- Develops tools and other materials for tracking of compliance management activities and analyzes trends
- Creates formal networks with key contacts across the department
- Assesses impact of client and regulatory observations on data integrity and/or quality management and provides recommendation for corrective action to the respective teams. Reviews and approves deviations and corrective actions and preventive actions (CAPAs)
- Develops and maintains applicable quality and site metrics. Participates on quality and business process improvement issues
- Handles delegated tasks and responsibility as requested by senior leadership. Represents RWDS QA at client audits and regulatory authority inspections.
- Maintains expertise with RWD-RWE regulatory requirements by attending external training programs, maintaining current reference library and attending FDA sponsored public conferences.

**Education and Experience**:

- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
- Must have 2 years of the 8 years QA experience in a pharmaceutical or hospital data setting

**Knowledge, Skills and Abilities**:

- Experience in technology implementation and change management
- Experience developing processes to support the development and evolution of product, including designing systems for collect

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