Sr Director, Quality Assurance Operations

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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 patients-first 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 Science's 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. That's why we've been named the No. 1 company to work for in the biopharma industry in Science's 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 Work-certified 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

Reporting to the Executive Director Quality GMP Compliance, the Director, Quality Operations will play a key role in managing QA oversight activities for Insmed. You will be responsible for Quality related activities for commercial products including transition from development (Phase III) into commercial. Role is also responsible for critical supplier relationships and active Quality engagement with these suppliers. Responsibilities

Role Responsibilities:

• Responsible for final product Quality release/rejection and related processes.
• Partner with other Regional Quality Directors to ensure transparent communication and assess any product related issues. Impact assessment includes proper evaluation for Health Authority reporting (FAR, Quality Defect, Recalls, etc) and escalation within QA.
• Responsible for supplier day to day relationships of critical suppliers. Using influence, active engagement, and an understanding of compliance requirements, work with critical suppliers to ensure quality, consistent supply.
• Review and approve deviations, CAPAs, SOPs and Change Control related to manufacturing operations
• Partners within QA team to execute supplier risk mitigation strategies, supplier assessments, and Quality Agreements. This may include active participation on Joint Steering Committees, frequent communication with QA Leadership, and direct support of Insmed Person In Plant (PIP).
• Responsible for QA representation in Design Control Process for medical device products and combination products.
• Lead the quality assessment for product lifecycle changes, efficiency projects, and continuous improvement projects.
• Manage the performance and development of 3-6 direct reports.
• Support supplier and internal audits as necessary.
• Create and maintain Standard Operating Procedures relating to areas of responsibility including product release, design control, etc.
• Act as company's representative during regulatory agencies and customer inspections.
• Supports the investigation of product and related CAPAs.
• Partner with colleagues in other departments to increase the overall effectiveness of the Quality Assurance department.
• Support Statistical Trending of Manufacturing and Analytical Data.
• Additional duties as assigned

Qualifications:

• BS degree in Chemistry, Engineering, Life Science or related discipline and a minimum of 15 years of relevant Quality Assurance experience; advanced degree and a minimum of 10 years relevant experience required
• Minimum 7 years' experience working in 21CFR211 regulated environment required
• Extensive knowledge of cGMPs and pharmaceutical and medical device manufacturing quality assurance.
• Commercial drug manufacturing site QA head experience preferred
• Ability to drive functional, technical, and operational excellence. Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness.
• Ability to solve complex problems and take proactive action
• Ability to motivate a team, recognize and develop good talent and bring out the best out of each individual.
• Maintain professionalism, self-motivation, and enthusiasm.
• Must be thoroughly knowledgeable on cGMP's, and familiar with other Regulatory Requirements applicable to a drug, medical device and combination product manufacturing.
• Must perform statistical analysis and capable of analyzing data to solve problems
• Direct experience with investigations and root cause analysis in pharmaceutical or medical device products.
• Experience with internal and external audits.
• Experience reviewing manufacturing validation documents.
• Preferred ASQ CQE and CQA Certifications.
• Medical device and Risk Management experience preferred, i.e. ISO 13485 and ISO 14971.
• Demonstrate ability to manage projects and variable workloads.
• Excellent communication and coaching 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).

Qualifications

• BS degree in Chemistry, Engineering, Life Science or related discipline and a minimum of 15 years of relevant Quality Assurance experience; advanced degree and a minimum of 10 years relevant experience required
• Extensive knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance.
• Commercial drug manufacturing site QA head experience preferred
• Ability to drive functional, technical, and operational excellence. Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness.
• Ability to solve complex problems and take proactive action
• Ability to motivate a team, recognize and develop good talent and bring out the best out of each individual.
• Maintain professionalism, self-motivation, and enthusiasm.
• Must be thoroughly knowledgeable on cGMP's, and familiar with other Regulatory Requirements applicable to a drug, medical device and combination product manufacturing and testing.
• Must perform statistical analysis and capable of analyzing data to solve problems
• Experience developing and overseeing laboratory SOPs and revisions according to FDA/ICH guidelines
• Solid knowledge of all QC laboratory equipment and manufacturing equipment
• Direct experience with investigations and root cause analysis in pharmaceutical or medical device products.
• Experience with internal and external audits.
• Experience reviewing manufacturing and QC validation documents.
• Preferred ASQ CQE and CQA Certifications.
• Medical device and Risk Management experience preferred, i.e. ISO 13485 and ISO 14971.
• Demonstrate ability to manage projects and variable workloads.
• Excellent communication and coaching 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).

Travel Requirements

Up to 30% travel, both domestic and/or international.

Salary Range

67 Compensation & Benefits

We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

• Flexible approach to where and how we work, regionally based
• Competitive compensation package including bonus
• Stock options and RSU awards
• Employee Stock Purchase Plan (ESPP)
• Flexible Vacation Policy
• Generous paid holiday schedule and winter break

ADDITIONAL U.S. BENEFITS:

• 401(k) plan with company match
• Medical, dental, and vision plans
• Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short and long-term disability benefits
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity insurance
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• Well-being reimbursement
• Paid leave benefits for new parents
• Paid time off to volunteer
• On-site, no-cost fitness center at our U.S. headquarters

Additional Information

Insmed Incorporated is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status . click apply for full job details

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