Associate Director, Quality Compliance

BioSpace; Bridgewater (MA); On-site; USD 139,000 - 196,000; Full time

Job summary

A leading biopharmaceutical company is hiring an Associate Director, Quality Compliance who will oversee quality assurance strategies and manage compliance activities. The role is pivotal for ensuring inspection readiness and internal audits across global sites. Candidates must have extensive quality experience and a strong understanding of regulatory requirements in the biopharma industry.

Benefits

Flexible approach to how we work

Health benefits and time-off plans

Competitive compensation package including bonus

Equity Awards (Long-Term Incentives)

Employee Stock Purchase Plan (ESPP)

Qualifications

• Minimum 10 years of relevant Quality experience required, 8 years for those with an advanced degree.
• Knowledgeable on Global drug cGMP's, ISO 13485, and regulatory requirements.
• Health Authority inspection experience is mandatory.

Responsibilities

• Ensure inspection readiness programs and manage internal audits.
• Coordinate the Field Alert Process and product quality defects.
• Create and maintain standard operating procedures.

Skills

Communication

Collaboration

Attention to detail

Leadership

Education

BS degree in Chemistry, Engineering, Life Science or related field

Job description

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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.

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

Associate Director, Quality Compliance will play a key role in setting strategy and handling QA Global Regulatory Compliance activities for Insmed in both the US and across global sites. This individual will be responsible for Insmed Inspection Readiness, key compliance issues, and Internal Audits. This position will partner to ensure overall effectiveness of the Quality Organization within Insmed. The scope of this role includes commercial and development activities.

Responsibilities

• Responsibilities:
• Partner with QA Leadership to ensure inspection readiness programs at global locations including on-going SME training, simulations, contact lists, introduction presentations and standard request readiness (complaint lists, deviation lists, SOP index, etc.), lessons learned. For US activities, act as the primary health authority inspection back room lead.
• Partner with QA leadership to communicate anticipated health authority inspections.
• Create, maintain/update and monitor the internal audit process including the annual schedule, reports and CAPA monitoring.
• Perform and/or coordinate all internal audits.
• Ensure Field Alert Process, product quality defects, and similar global events are assessed per the appropriate timelines. Ensure documentation and events are tracked to closure and reported on in Quality metrics.
• Mange global mock recall on an annual basis.
• Act as coordinator for any recalls
• Create and maintain Standard Operating Procedures relating to areas of responsibility including Internal Audits, Health Authority Inspections, Field Alerts, Recalls etc.
• Partner with business collaborators and QA Leadership to ensure overall effectiveness of the Global Quality Organization.
• Lead Insmed Quality Intelligence team for regulation changes
• Support key investigations
• Other duties as assigned
• Qualifications:
• BS degree in Chemistry, Engineering, Life Science or related field required.
• A minimum of 10 years of relevant Quality experience of increasing levels of responsibility required. Candidates with an advanced degree (MS) and a minimum of 8 years relevant experience will also be considered.
• Must be thoroughly knowledgeable on Global drug cGMP's, ISO 13485, and familiar with other Regulatory Requirements applicable to a medical device and combination product manufacturing operation.
• Auditing experience required
• Direct Global Quality experience preferred.
• Must have had Health Authority inspection experience.
• Must have direct experience with GMP compliance responsibilities, Inspection Readiness Programs, in pharmaceutical and/or medical device products.
• Experience with internal and external audits.
• ASQ CQA or similar Certification preferred.
• Must be able to partner and collaborate well cross functionally, at all levels.
• Must have excellent communication and influence skills (verbal and written).
• Should demonstrate the ability to manage projects and variable workloads.
• Acts in a highly organized manner with a strong attention to detail, clarity, accuracy and conciseness.
• At Insmed, we're committed to investing in every team member's total well-being, 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 time-off plans
• Competitive compensation package, including bonus
• Equity Awards (Long-Term Incentives)
• Employee Stock Purchase Plan (ESPP)
  
  
  

Salary Range

$139,000 - $195,200 a year

Compensation & Benefits

At Insmed, we're committed to investing in every team member's total well-being, 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 time-off plans
• Competitive compensation package, including bonus
• Equity Awards (Long-Term Incentives)
• Employee Stock Purchase Plan (ESPP)
  
  
  

For more information on U.S. benefits click here.

Additional Information

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. 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 at [e-mail] and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case 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.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Internet News

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