Director Of Quality Assurance

Description

The Director of Quality Assurance has overall responsibility for providing leadership and direction for all Quality Assurance programs and for ensuring compliance with all relevant FDA regulations and guidelines as they pertain to marketed drug products. This includes overseeing the preparation and approval of master batch documents, SOPs, specifications and protocols. Also responsible for the release of raw materials, packaging components, in-process and finished products. In addition, duties include coordination of GMP training and internal and vendor compliance audits, oversight of validation projects, facility / process and equipment change control, investigation of procedural deviations, nonconformances, customer complaints and environmental anomalies. Primary liaison for client and regulatory audits. The Director of Quality Assurance has responsibility for the company's Quality Management System; and for the assurance of drug quality, strength, identity, and purity throughout the manufacture, processing, packing, testing, and holding of the drug product.

Skills

Gmp, Chemistry, fda inspections, batch record, deviation management, capa, management skills, Supervision, Process improvement, quality control

Top Skills Details

Gmp,Chemistry,fda inspections,batch record,deviation management,capa,management skills

Additional Skills & Qualifications

Monday-Friday Core hours: 8:00 AM - 4:30 PM (some flexibility) 100% onsite Essential Knowledge / Experience A B.S. in a science discipline (Chemistry, Biology, Pharmacy) or a related field Minimum of 5+ years of managerial experience in a related field Preferably within the pharmaceutical industry, specifically in a Quality Assurance environment Thorough experience in all aspects of Quality Assurance functions In-depth knowledge of cGMPs Physical / Mental / Visual Demands Strong communication skills (written and verbal) Negotiation skills Interpersonal and analytical abilities Problem-solving capability Technical and motivational skills Ability to retain and handle confidential information Responsibility for Safety of Others The Director of Quality Assurance is responsible for ensuring a safe working environment for all QA personnel Facility-wide responsibility to identify and report any unsafe conditions

Experience Level

Expert Level

Job Type & Location

This is a Permanent position based out of Brockton, MA.

Pay and Benefits

The pay range for this position is $130000.00 - $140000.00/yr.

health vision dental 401K

Workplace Type

This is a fully onsite position in Brockton,MA.

Application Deadline

This position is anticipated to close on Jun 9, 2026.

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.

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 [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: 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.

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.