In this role, the Quality Control Compliance Senior Specialist / Manager will be responsible for and involved in various aspects of QC compliance including inspection readiness activities, quality systems, training and document control. The successful candidate will be required to work with a broad team including QA, Analytical Sciences & Technology, Global QC, Digital Lab Systems, Manufacturing, and Global QC. Accordingly, this position will be expected to work in a highly collaborative, cross-functional manner and provide compliance guidance and oversight to the entire QC department.
Here’s What You’ll Do
• Lead and oversee the QC area inspection readiness program, performing routine walkthroughs and area reviews; provide feedback on compliance gaps and recommend plans for correction.
• Identify areas within QC for continuous improvement, propose compliant solutions and independently implement.
• Author and/or participate in QC related deviations, OOS investigations and lab events.
• Lead and/or participate in the implementation of meaningful and effective corrective actions for deviations, OOS investigations and lab events.
• Work with the QC Review and Document Control teams to ensure all laboratory testing and support documentation is reviewed, closed out and archived within appropriate timeframes per established procedures.
• Revise QC SOPs, forms, work instructions and other documentation as required to ensure clarity of procedures, appropriate level of instructions and compliance to regulatory requirements
• Represent QC Compliance in cross-functional meetings regarding inspection readiness, deviations, CAPAs and change controls.
• Track, monitor and report on compliance related metrics in various forums, including presentations to key leadership and stakeholders.
• Perform various document reviews as the QC Compliance stakeholder, as assigned.
• Accept, complete, and report on special assignments within the agreed upon timeframe as assigned.
• Perform all job functions with adherence to all relevant procedures, GxP, cGMP and associated regulatory requirements.
Here’s What You’ll Need (Minimum Qualifications)
• Minimum 5-8+ years of QC and/or QA experience in a pharmaceutical cGMP setting.
• B.S. degree in relevant scientific discipline.
• Excellent technical writing skills and experience authoring deviations, investigations, and procedures in a cGMP setting.
• Knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
• Excellent ability to communicate in a scientifically sound and understandable manner.
• Demonstrated ability to prioritize, manage and complete multiple projects and tasks in a fast-paced environment effectively and independently.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• Ability to navigate through ambiguity and rapid growth and adapt to change.
Here’s What You’ll Bring to the Table (Preferred Qualifications)
• MS in a relevant scientific discipline with 2-5+ years QC and/or QA experience in a pharmaceutical cGMP setting.
• Previous experience in a laboratory compliance function within QC or QA.
Norwood MA: Sr. Specialist / Manager (232363)