Sr Director Quality Assurance

Sr Director of Quality AssuranceMUST HAVE

• Director or Sr Director Experience

• Requires a BS/BA degree in a scientific discipline

• Minimum of 10+ years of experience in Quality Assurance in the Pharmaceutical, Biotech, and/or Medical Device industry

• Radiopharmaceutical experience a plus

• Proficiency and knowledge of cGMPs, FDA, EMA, and ICH regulatory standards

• Experience working with CMOs

Job Description

Collaborate with cross-functional leaders to identify Quality program requirements. Develop and maintain a comprehensive plan to optimize resources across Quality Assurance functional groups. Evaluate existing processes and compliance activities to identify and remediate gaps. Provide technical leadership to the QA/QC and Manufacturing & Supply Chain organizations, and technical support for validation activities, Quality Event investigation, and CAPA remediation. Design and implement a successful strategy for QA oversight within internal Manufacturing and ensure resources are allocated to meet strategic quality oversight initiatives. Ensure deviations, CAPA, and investigations are well-written and comprehensive with thorough risk analysis assessments and use of root cause analysis tools. Ensure investigations are complete. Ensure the review and approve/reject production batch records and investigate any unexplained discrepancies. Assure continuous compliance to all relevant domestic and international cGMP requirements, effective risk management, and collaboration between QA teams.

Responsibilities

• Identify Quality program requirements in collaboration with cross-functional leaders.

• Develop and maintain a comprehensive plan to optimize resources across Quality Assurance functional groups.

• Evaluate existing processes and compliance activities to identify and remediate gaps.

• Provide technical leadership to QA/QC and Manufacturing & Supply Chain organizations.

• Support validation activities, Quality Event investigation, and CAPA remediation.

• Design and implement a successful strategy for QA oversight within internal Manufacturing.

• Allocate resources to meet strategic quality oversight initiatives.

• Ensure deviations, CAPA, and investigations are comprehensive with thorough risk analysis assessments and use of root cause analysis tools.

• Review and approve/reject production batch records and investigate any unexplained discrepancies.

• Assure continuous compliance to all relevant domestic and international cGMP requirements and effective risk management.

Essential Skills

• Quality assurance

• CAPA

• Investigation

• Deviation

• Trackwise

• Audit

• Validation

• LIMS

• FDA

• CMO

Work Environment

The Director of Quality Assurance will oversee a total of 15 people, including 6 individuals in quality release, 5 in quality systems, and eventually 2 in validation. The role requires a detail-oriented individual with strong communication skills to oversee and implement specific changes within the department. The work schedule is Monday through Friday, 9:00 am to 5:00 pm, with 4 days onsite and Fridays remote. The environment is business casual.

Pay and Benefits

The pay range for this position is $230000.00 - $270000.00

They will get holiday/vacation/benefits with stock options. It will potentially include a company wide holiday shutdown at the end of the year which was a trial run this year.

Workplace Type

This is a hybrid position in North Billerica,MA.

Application Deadline

This position will be accepting applications until Jan 22, 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 ~~~ (~~~) for other accommodation options.