Manager, Quality and Compliance (US)

April 11

OPEN Health

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Market Access • Brand Communications • Medical Communications • Market Research • Public Relations & Advertising

501 - 1000

Description

• Works closely with the Associate Director and Evidence and Access (E&A) Senior Leadership Team • Manages company Standard Operating Procedures (SOPs) and Working Guidelines (WGs) • Internally audits and drives compliance with OPEN Health E&A policies and procedures • Qualifies sub-contractors and third-party suppliers • Supports compliance training and data privacy initiatives • Reports adverse events/serious adverse events • Keeps up to date on quality standards, best practices, and regulatory requirements • Maintains thorough working records and ensures compliance with data privacy regulations • Supports problem-solving, project delivery, and senior decision-making

Requirements

• A degree in life science or equivalent with a minimum of 2 years’ experience in a quality or compliance environment • Experience in healthcare or scientific research industry with understanding of regulatory requirements • In-depth knowledge of quality systems, preferably within the pharmaceutical industry • Excellent written and verbal communication skills • Experience of writing clear process documents • Strong organizational and attention to detail skills • Proficiency in MS365 including Word, Excel, Power Point, Outlook, and Teams

Benefits

• Competitive pay • Generous paid vacation and holidays • Health insurance programs across all locations