Sr Manager Quality Assurance GMP
Sr Manager Quality Assurance GMP
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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
- Responsibilities:
- Provide QA support for GTx clinical and precommercial product disposition and distribution. Responsible for working in coordination with the GTx site quality groups.
- Responsible for review and approval of master batch records for preclinical / clinical and / or precommercial product.
- Manage the quality aspects of clinical project from raw materials to manufacturing to packaging distribution and release
- Focus on establishing implementing and maintaining quality operations systems that support manufacturing activities
- Perform ongoing review of batch records as part of product release oversight of deviations and CAPAs and ensuring appropriate communication of issues development and plans.
- Serve as a conduit from the local QA organization to Global QA organization.
- Establish qualitytoquality relationships with CDMOs
- Support application of phase appropriate quality requirements
- Responsible for assisting in any Health Authority inspection preparation acting as SME when needed and in providing or reviewing responses to findings from such inspections.
- Responsible for release or rejection of GMP materials and coordinate with QA staff to manage the timeline and assure on time delivery of approved materials
- Develop the required working relationships both with the GTx Technical Operations and broader QA teams.
- Perform audits write reports and follow up on audit responses and CAPA implementation.
- Establish Quality Agreements with GTx Technical Operations and CDMOs associated vendors and contracted laboratories.
- Apply Quality Risk Management for key processes and systems. Identify improvement opportunities and implement changes as vital.
- Partner with colleagues in other departments to increase the overall effectiveness of the Quality department
- Assist in other quality assurance related activities as agreed with management.
- Knowledge & Experience
- 7 years experience in Pharmaceutical Industry in a similar function.
- Full understanding of GMP and Gene Therapy manufacturing.
- Familiarity with Quality Assurance aspects in manufacturing processes of new products.
- Experience with effectively managing regulatory agency inspections working with regulators and vendor/supplier audits.
- Broad knowledge of riskbased quality systems approaches consistent with ICH Q10 for pharmaceuticals.
- Qualifications
- Minimum bachelors degree in Pharmacy Chemistry Life Science or related field is required.
- Skills
- 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).
- Other (if applicable):
- Function involves up to 40 travel
- This position reports to Insmed Gene Therapy located in San Diego California.
- Must successfully exhibit Insmeds five 5 corporate values: Collaboration Accountability Passion Integrity & Respect; along with any other position specific competencies.
- Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.
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:
Director
Employment Type
Unclear
