Regulatory Affairs Specialist

Job Description

We're Hiring: Site Quality and Compliance Lead

The Site Quality and Compliance Lead is fundamental to driving the quality in and the compliance of the planning, preparation and conduct, including monitoring of clinical programs for Phase I-IV national and international trials, Expanded Access Programs, Registries and Survey trials across Clinical Development Operations (CDO). The lead also plays a critical role in developing and delivering CDO training programs effectively.

Key Responsibilities

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• The Lead is responsible for implementation of quality activities and inspection readiness. As directed by Team Lead, participates in and contributes to global functional quality network initiatives.
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• The Site Quality and Compliance team as a whole ensures Quality activities are conducted in compliance with governmental regulations (i.e., FDA/ICH/GCP), company SOPs, and local working instructions, and business ethics while adhering to financial targets.
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• The Lead will develop and deliver just in time training initiatives to the US CDO organization.
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• This role plans and coordinates assigned training initiatives to ensure timely delivery of high-quality project outcomes within set timelines and financial targets. The Lead supports curriculum development by analyzing course materials and training methods across CDO roles.
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• The Lead delivers on their tasks by working in collaboration with cross-functional partners in US CDO, Legal, and other Med/RA functions to facilitate the communication necessary to drive the quality in the planning, preparation and conduct, including monitoring of clinical programs, and execution of quality activities across Clin Ops.
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• Works in collaboration with Quality Medicine and other cross-functional partners to assist in activities addressing findings related to sponsor inspections and/or internal audits focused on CDO.
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• Proactively identifies, supports and assists in the development and implementation of CD&O Quality activities and inspection readiness. Perform quality reviews, as assigned, including review of BI processes.
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• Act as primary point of contact for US CD&O non-compliances for triage to Quality Medicine partners. Collaborate for resolution.
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• Maintain working partnership with Quality Medicine, cross-functional partners in rest of CD&O, Legal, and other Med/RA functions. Executes coordinated programs of CD&O Quality activities based on common goals and objectives.
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• At direction of Team Lead, participates in and contributes to global functional quality network initiatives.
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• Participate in site non-compliance meetings, as appropriate to assist trial teams in the development of Corrective and Preventive Action (CAPA) Plans. Serve as CAPA champion, as required.
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• Executes the reporting of quality metrics to assess quality trends, individual performance needs and/or compliance issues. Identify potential areas of risk and collaborate with CD&O team members in establishing risk mitigation strategies.
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• Support execution of onboarding to US CDO & Medicine, process improvement initiatives, including training programs to address quality and/or performance issues.
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• Ensures trends or lessons learned are disseminated to the US CDO organization on a routine cadence.
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• Perform all company business in accordance with all regulations (EEO, FDA, ICH, DEA, OSHA, PDMA, PhMRA, etc.) and company policy and procedures. Demonstrate high ethical and professional standards with all business contacts in order to maintain an excellent reputation within the medical and pharmaceutical community.
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Skills

Functional Competencies

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• Knowledge of Pharmaceutical Life Cycle Process - Level 3 - Influencing
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• Knowledge of Regulatory Requirements & Compliance - Level 3 - Influencing
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• Knowledge of Technology Trends - Level 2 - Demonstrating
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• Project/Program Management - Level 3 - Influencing
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Core Competencies

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• Business/Technical Knowledge - Level 2 - Demonstrating
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• Communication - Level 3 - Influencing
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• Customer Orientation - Level 2 - Demonstrating
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• Delivering Results - Level 3 - Influencing
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• External Focus - Level 2- Demonstrating
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• Fast and Focused Execution - Level 3 - Influencing
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• Innovation and Change - Level 2 - Demonstrating
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• Planning and Organization - Level 2 - Demonstrating
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• Quality Orientation/Business Process Excellence - Level 3 - Influencing
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• Lives Lead & Learn - Level 2 - Demonstrating
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• Teamwork and Collaboration - Level 3 - Influencing
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• Winning Vision - Level 3 - Influencing
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Management Competencies

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• Growing Talent - Level 2 - Demonstrating
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• Managing Performance Level 2 - Demonstrating
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Foundational Competencies

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• Accountability and Ownership
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• Integrity and Trust
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• Values Diversity and Inclusion
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Current knowledge in and adherence to government regulations (eg., FDA, ICH, GCP)and ability to gain knowledge of company SOPs, Local Working Instructions and role specific training.

Education

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• Bachelors Degree (Highly preferred in life sciences)
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Aequor Technologies LLC is an Equal Opportunity Employer. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected status.