Compliance Manager - GxP Vendor Quality

Job Description

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD (a division of Thermo Fisher Scientific) — 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 Compliance Manager you will support PPD’s Vendor Quality Management, with a focus on PPD’s clinical (GCP) providers, by providing regulatory and quality support through the full vendor lifecycle for PPD sub-contracted vendors who provide GxP-regulated products and/or services to PPD and/or clients.

Summarized Purpose

Supports PPD’s Vendor Quality Management team, with a focus on PPD’s clinical (GCP) providers. Promotes awareness of quality and regulatory compliance standards and trends for GXP Vendors. Participates in vendor quality improvement activities. Oversees governance and compliance management processes; implements quality awareness objectives; develops and maintains vendor quality and compliance guidance/reference materials and tools and provides any other support or knowledge necessary to advance the vision of the department

Essential Functions

• Supports the Vendor Quality Management team by initiating vendor audits and ensuring audit compliance, negotiating vendor quality agreements, establishing, tracking, and analyzing vendor quality metrics, tracking, escalating, reviewing, approving, and performing trending on Vendor Quality Events, maintaining vendor information in the PPD Vendor Management System
• Establishes Quality to Quality relationships with external suppliers to align and drive efficient collaboration while leading and participating in vendor process quality improvement initiatives
• Develops vendor tools and other materials for tracking of compliance management activities
• 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 tools and other materials for tracking of compliance management activities.
• review, audit and inspection support, CAPA development, and Quality Plan development and execution.
• Oversees governance and compliance management processes; implements quality awareness objectives; develops and maintains quality and compliance guidance/reference materials and tools and provides any other support or knowledge necessary to advance the vision of the Global Quality and Compliance (GQ&C) group.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

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).

Knowledge, Skills And Abilities

• Proven oral and written communication skills
• Strong influencing and motivational 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
• Strong writing and computer skills; ability to learn and become proficient with appropriate software
• Ability to multitask and prioritize competing demands/work load
• Proven flexibility and adaptability

Working Environment

• PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.

Below is listed the working environment/requirements for this role :

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.