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Compliance Manager

4 months ago

Pretoria, South Africa Thermo Fisher Scientific Full time

**PPD, now Thermo Fisher's clinical research business, is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.**

**At PPD, we are passionate, deliberate, and driven by our purpose
- to improve health**

**Accelerated Enrollment Solutions (AES) is a business unit of PPD that helps biopharmaceutical companies overcome patient recruitment and research site challenges by optimizing each step in the patient journey to deliver greater speed, certainty, and control to clinical trial delivery.**

Our colleagues in corporate 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 Compliance Manager you will develop and implement quality and compliance strategies and initiatives across the organization.

**Key responsibilities are as follows**:

- Leads quality and compliance processes and engages with cross-departmental staff to ensure appropriate execution and completion (e.g. quality events, inspections and audits, vendor oversight).
- Develops guidance and reference information, repositories, and communication channels (e.g. requests for information/ proposals (RFI/RFP), policies, procedures, guidance documents, or quality management systems training).
- Leads and/or participates in process/quality improvement initiatives.
- Develops and maintains quality and compliance guidance/reference materials and tools.
- Creates formal networks with key contacts across the department.

AES #LI-TK2

**To be considered for this exciting opportunity you will require the following skills and experience**:

- Great interpersonal skills
- Strong influencing and motivation skills
- Demonstrated organizational and time management skills
- Extensive knowledge of the clinical trial process
- Comprehensive understanding of ICH GCP and other relevant regulations and guidelines
- Effective negotiation and problem-solving skills
- Ability to multitask and prioritize demands/workload
- Flexible and adaptable person

**Our 4i Values**:
**Integrity - Innovation - Intensity - Involvement