Director Of Quality

Job Title: Director of Quality

Help support and oversee the quality group, with a focus on compliance and auditing to ensure alignment with pharmaceutical and medical device regulations. Work to handle inspection readiness, internal audit programs, external audits, compliance, customer complaints, and quality management reviews. Act as the process owner of quality events, deviations, non-conformance CAPA, change control, document control, and training. Support the development of quality systems and handle compliance surveillance.

Job Description

Help support and oversee the quality group, with a focus on compliance and auditing to ensure alignment with pharmaceutical and medical device regulations. Work to handle inspection readiness, internal audit programs, external audits, compliance, customer complaints, and quality management reviews. Act as the process owner of quality events, deviations, non-conformance CAPA, change control, document control, and training. Support the development of quality systems and handle compliance surveillance.

Responsibilities

• Support and oversee the quality group with a focus on compliance and auditing.
• Ensure alignment with pharmaceutical and medical device regulations.
• Handle inspection readiness and internal audit programs.
• Manage external audits and compliance.
• Address customer complaints and conduct quality management reviews.
• Act as the process owner for quality events, deviations, non-conformance CAPA, change control, document control, and training.
• Support the development and implementation of quality systems.
• Handle compliance surveillance.

Essential Skills

• Compliance
• Audit
• External audit
• Quality assurance
• CAPA
• Change control
• Document control
• Quality systems
• Customer complaints
• Regulatory
• Risk management
• Reporting

Additional Skills & Qualifications

• Bachelor's degree in a related medical, science, or business discipline.
• Minimum 15+ years' functional experience in Quality within the pharmaceutical, biopharmaceutical, medical device, or equivalent industries.
• Equivalent combination of education and experience.

Work Environment

This person will work 100% onsite with occasional work from home on Fridays due to the on-the-floor support and audit readiness team requirements. The working environment is business casual, and the role operates during the first shift, Monday through Friday.

Job Type & Location

This is a Permanent position based out of North Billerica, MA.

Pay and Benefits

The pay range for this position is $175000.00 - $224000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

We have the company benefits on file and can share as candidates go through the interview process. They have holiday, vacation, 401k. They also will get a bonus and high amount of equity.

Workplace Type

This is a fully onsite position in North Billerica,MA.

Application Deadline

This position is anticipated to close on Feb 28, 2025.

Equal Opportunity Employer

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io for other accommodation options.

Massachusetts Lie Detector Notice

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Contact Information Collection

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Use of Artificial Intelligence (AI)

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.