Quality, Capability & Risk Manager, USA

Global Clinical Operations is transforming to fulfil our vision to “Be the best performing and trusted Global Clinical Operations organization”. Our mission is to “Accelerate the pipeline through innovative, efficient and expeditious delivery of high-quality data”.

To work with the Director Regional Risk Management & Management Monitoring to ensure that Clinical Research activities are conducted by local/regional Clinical Operations Staff in accordance to ICH GCP, relevant international and local regulations, requirements and guidelines, as well as GSK written standards.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Extended member of the local Clinical Operations Leadership Team.
• Responsible for all local Clinical Operations quality issues to ensure that clinical research activities are conducted according to ICH GCP, local legislation and GSK written standards.
• Assess potential regulatory compliance/quality issues and risks in clinical research activities conducted by local Clinical Operations staff and to ensure that these risks are properly managed, documented and escalated as appropriate within GSK. Responsible for the development and maintenance of a local Risk Register, Quality Plan and delivering all aspects of management monitoring activities in partnership with the business.
• Support all assessments and inspections.
• In collaboration with the Capability Building Team and local Clinical Operations Leadership Team, to ensure that local Clinical Operations staff have the appropriate technical capabilities and are appropriately trained to effectively conduct clinical research activities and receive the required ongoing training to meet the changing regulatory environment and updates to GSK written standards. Accountable to design (when required), develop (when required) and deliver training identified globally and at a local level to support clinical operations processes and GSK written standards.
• Responsible to implement ongoing quality improvement processes, maintain local written standards.
• Share best practices and collaborate with other Quality Capability and Risk Managers on ways of working for regional and global impact.
• To act as the local ambassador for Quality, Capability and Risk Management team activities.
• To maintain an external focus, via industry consortia, industry networks and country regulatory forums to identify emerging trends in quality and compliance which may impact at the regional and country-level.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor of Science Degree or equivalent in life sciences, medicine, clinical research, pharmacy
• 5 + years' experience in Clinical Operations.
• Advanced knowledge of the drug development processes and key operational interfaces.
• Experience with CH GCP requirements, and local and global regulatory requirements applying to Clinical Trials.
• Experience with clinical/corporate governance principles
• Negotiations experience
• Experience in MS Office (PowerPoint, Excel, Word & Outlook)

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Master of Science or equivalent.
• High degree of organizational awareness;
• Ideally have previous experience in quality management
• Good written and verbal communication skills in English.
• Demonstrated ability to develop solutions to complex problems with regard to quality and governance.
• Excellent understanding of clinical research and the drug development process.
• Excellent knowledge of ICH GCP / IND guidelines
• Excellent knowledge of global and local GSK written standards.
• Sound understanding of the Internal Control Framework
• Can work both independently on projects and also part of a team.
• Creative, logical, strategic thinker
• Effective problem solver and conflict resolution
• Good eye for detail and high learning agility
• Able and willing to travel as required for the role.
• Collaborative and open leadership style

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk
• Managing individual and team performance.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Implementing change initiatives and leading change.
• Sustaining energy and well-being, building resilience in teams.
• Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
• Developing people and building a talent pipeline.
• Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
• Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
• Budgeting and forecasting, commercial and financial acumen.

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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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