Associate Manager - Investigation

Role overview

Responsibilities

• Investigate deviations, out-of-specification results, and atypical cases.
• Identify root causes and recommend corrective action plans.
• Prepare reports compliant with regulatory requirements and company policies.
• Plan short-term work, meet targets, resolve moderately complex problems, and periodically review work.

Minimum requirements

• BA/BS with at least 2 years' experience; MBA/MS with any years' experience; associate's degree with at least 6 years' relevant experience; or high school diploma/equivalent with at least 8 years' relevant experience.
• Requires problem-solving and decision-making skills, pharmaceutical industry experience, and knowledge of manufacturing, compliance, and technology investigations, processes, and systems.
• Requires independent and collaborative working ability, effective written and verbal communication, computer literacy, and superior Excel spreadsheet skills.

Preferred qualifications

• A master's degree is preferred.
• Investigation experience, including conducting and writing investigations using a methodology, is preferred.
• Familiarity with regulatory requirements and quality standards, root cause analysis, and corrective action plans is preferred.
• Analytical and critical thinking, multitasking, organization, mentoring, and collaborative interpersonal skills are preferred.
• Experience with generative AI tools such as ChatGPT or Microsoft Copilot and responsible AI practices is preferred.

Work location

• Work location assignment is on premise.