Manager Quality Control
Manager Quality Control
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Salary Not Disclosed
1 Vacancy
Job Description
Company Description
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees and everything we do is motivated by a patientsfirst mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo solve problems and work collaboratively with a sense of urgency and compassion.
Guided by our core values of collaboration accountability passion respect and integrity we aim to foster an inclusive diverse and flexible work environment where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry come to Insmed to accelerate your career.
Recognitions
Consistently Ranked Sciences Top Employer
Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day our employees turn their passion for science and research into innovative solutions for patients. Thats why weve been named the No. 1 company to work for in the biopharma industry in Sciences Top Employers survey for four years in a row.
A Certified Great Place to Work
We believe our company is truly special and our employees agree. In July 2024 we became Great Place to Workcertified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma Best Workplaces in New York PEOPLE Companies That Care Best Workplaces for Women Best Workplaces for Millennials and Best Medium Workplaces lists.
Overview
Responsibilities
- Handles contract laboratory vendors supervises laboratory performance assesses capability and ensures actions are taken to improve if needed.
- Point person for weekly communications with external labs for status updates and testing activities.
- Measure performance against established Key Performance Indicators (critical metrics) thereby consistently ensuring timely and accurate testing reporting and release.
- This role will review assemble and trend release IPC and stability data generating reports as necessary.
- Lead and assist in identifying changes to the processes and impact on the product quality and established procedures.
- Ensures all Out of Specification / Out of Trend results are thoroughly investigated with root cause identified and appropriate corrective actions implemented.
- Handle method transfer method development and validation activities at external lab site
- Notifies laboratory management when unusual results trends or data deviations occur.
- Presenting potential issues/obstacles and advancing as vital
- Assist in the development of new processes and process improvements.
- Crossfunctional liaison working closely with internal collaborators.
- Statistical programming and data management support is a plus.
- Develop statistical analysis plans if needed including the definition of derived data sets and the design of templates for statistical tables figures data listings and/or graphs for clinical summary reports.
- Perform statistical analyses and interpret results of these analyses.
- Supply to internal development projects as the need arises.
- Provide mentorship support and training to internal / external staff as the need arises.
- The position requires a BS or BA degree or equivalent in a science or health care field with a preferred focus on chemistry biochemistry microbiology physics science program
- 5 years in the pharmaceutical industry with a GMP testing focus ideally covering the analytical method and testing lifecycle from development through commercial drug product testing.
- Knowledge of QC processes and procedures and GMP regulations and mentorship with shown efficiency in maintaining QC processes for compliance with regulations.
- Expertise in method verification and validation procedures.
- Knowledge of Statistical programming.
- Excellent presentation skills both verbal and written.
- Ability to define problems collect data establish facts and draw valid conclusions required.
- Ability to establish and maintain collaborative working relationships with internal and external partners required.
- Ability to take initiative and work independently while optimally handling timelines required.
Salary Range
Compensation & Benefits
At Insmed were committed to investing in every team members total wellbeing now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members regardless of geographic location:
- Flexible approach to how we work
- Health benefits and timeoff plans
- Competitive compensation package including bonus
- Equity Awards (LongTerm Incentives)
- Employee Stock Purchase Plan (ESPP)
For more information on U.S. benefits click here.
Additional Information
Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex gender identity sexual orientation race color religion national origin disability protected Veteran status age or any other characteristic protected by 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.
Insmed is committed to providing access equal opportunity and reasonable accommodation for individuals with disabilities in employment its services programs and activities. To request reasonable accommodation to participate in the job application or interview process please contact us by email atand let us know the nature of your request and your contact information. Requests for accommodation will be considered on a casebycase basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Required Experience:
Manager
Employment Type
Unclear
