Lead Quality Assurance Director for Pharmaceutical Operations

4 days ago

Bridgewater NJ USA, United States Insmed Incorporated Full time

At Insmed Incorporated, we are committed to transforming the lives of patients living with serious and rare diseases. As a global biopharmaceutical company, we strive to foster an inclusive, diverse, and flexible work environment where our employees can thrive.

Overview

The Director, Quality Operations will play a pivotal role in managing QA oversight activities for Insmed. This individual will be responsible for quality-related activities for commercial products, including transitioning from development to commercial phases. The role also involves critical supplier relationships and active quality engagement with these suppliers.

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 day-to-day relationships of critical suppliers. Using influence, active engagement, and an understanding of compliance requirements, work with critical suppliers to ensure quality and consistent supply.
  • Review and approve deviations, CAPAs, SOPs, and Change Control related to manufacturing operations.
  • Partners within the 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 the 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 21 CFR 211 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 cGMPs 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).
Compensation and Benefits

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 online 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.

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