Job Title: Director of Quality

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.

Pay and Benefits

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

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 14, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

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 actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $175,000 - $224,000