Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employeesbrings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.
Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference.
Reporting to the Associate Director of Quality Assurance, the Manager Quality Systems will play a key role in managing QA and Regulatory Compliance activities for Insmed. This role directly influences Insmed GMP compliance through QA oversight, monitoring and review of Quality System activities. In coordination with the Associate Director, specific areas of responsibility include: oversight of Change Control Committee, approval of Change Controls, Monthly/Quarterly Quality System Metrics, Complaint Investigations/Trending, Deviation/CAPA/EC monitoring and approvals, and related SOPs for these systems.
- Oversee processes within the QMS including Change Control, Deviations, Laboratory Investigations, and CAPA. This includes process design, monitoring for compliance, continuous improvement activities, metrics, and day-to-day operations for the specified QMS processes.
- Manages the change control program and lead the Change Control Committee. Ensures adherence to internal procedures and industry/regulatory expectations related to controls and documentation before, during, and after Change Control execution.
- Performs QA review and approval of deviations, laboratory investigations, CAPAs, and change controls. Ensures completeness, accuracy and compliance to all applicable cGMP regulations.
- Reviews and evaluates corrective/preventive actions (CAPA) including the CAPA effectiveness program. Responsible for communicating CAPA status to cross-functional departments and external partners.
- Leads the investigation of complex deviations, and product complaints. Ensures thorough investigations are conducted using various root cause analysis techniques and that all investigations are technically sound/properly documented, with corrective actions for prevention of reoccurrence identified.
- Tracking and identifying trends of quality events, including but not limited to complaints.
- Handles compilation of quality metrics for monthly trending, management review meetings and follow up for the closure of process improvements. Presentation and communication of trending reports in respective Quality forums.
- Reviews and updates SOPs, policies and standards regularly to ensure compliance with GxP standards, FDA/EMA/ICH and other applicable competent authority regulations and requirements.
- Identifies and implements process improvement projects to drive success in the areas of Quality Management Systems.
- Assists in inspection readiness activities and plays a key role during inspections/audits.
- Provided support during internal review, Audits, FDA Audits and Third-party consultant Audits.
- BS degree in Chemistry, Life Science or related discipline required.
- A minimum of 5 years of relevant Quality Assurance experience required; Candidates with an advanced degree (MS) and aminimum of 3 years relevant experience will also be considered.
- Direct experience with Change Control, Deviations/CAPAs, and Complaints in pharmaceutical or medical device products.
- Full understanding of cGMPs for pharmaceutical products.
- Familiarity of pharmaceutical product manufacturing processes, medical devices, and analytical laboratory practices.
- Experience at reviewing manufacturing investigations, lab investigations, and change controls.
- Broad knowledge of risk-based quality systems approaches consistent with ICH Q10 for pharmaceuticals and/or ISO 14971
- Demonstrate ability to manage projects and variable workloads.
- Must have excellent communication skills (verbal and written).
- Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Proficient in analyzing data trends in Excel or Minitab.
- Preferred ASQ CQE certification.
Insmed is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.