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Job Title: Quality Assurance ManagerJob Description

The Quality Assurance Manager provides leadership and guidance for the department, works to improve core processes, and manages projects. This role ensures that the staff is qualified in all quality area functions and that the Quality Management System (QMS) is maintained to applicable Good Manufacturing Practice (GMP) requirements.

Responsibilities

• Identify areas of continuous improvement within the Quality department and in the Quality Management System.

• Evaluate metrics for trends to better focus on areas requiring improvement. Develop goals for the Quality Assurance team to drive improvement and monitor for effectiveness.

• Develop and perform training for the Quality team as well as other departments in areas of the PPS QMS and GMP requirements.

• Support the Quality teams in regard to projects including but not limited to commercial and clinical batches, Operational, QC, and QMS projects.

• Lead and support with customer requests, quality events, and other activities.

• Maintain an electronic documentation control system assuring all documents are current. Act as the system administrator.

• Support the teams as the system SME and/or administrator for creating CAPAs, change controls, deviations, and laboratory investigations.

• Exhibit strong communication and problem-solving skills while leading the Quality Assurance department toward company goals and objectives.

• Provide guidance and leadership to the QA Specialists with input into their performance and goals.

• Provide compliance support and expertise for the QA department.

• Support the execution of audit readiness programs to ensure compliance readiness at all times for customer and regulatory audits.

• Maintain tracking mechanisms to support various QA-related metrics.

• Continuously monitor and review QA systems and procedures for adherence to regulatory compliance, quality improvements, efficiency, and industry best practices.

• Participate in site quality and process improvement initiatives. Represent QA on site project teams.

• Effectively lead the team to deliver goals/results. Provide coaching and necessary resources to area management to meet department objectives.

• Conduct interviews and hire qualified candidates to fill open technical and support positions.

• Conduct performance and development reviews.

• Provide direction and leadership for the QA team in compliance, systems, commercial, pre-commercial processes, support for development, manufacturing, and supply chain operations.

• Develop and manage daily work schedules for QA Specialists to meet QA delivery schedules and needs.

• Ensure QA documentation and batch release are completed by due dates and project timelines.

• Lead the design, implementation, and continuous improvement of QA Operations, Systems, and Compliance to promote efficient and compliant operations.

• Provide support for the implementation of new and key process optimizations.

Essential Skills

• Bachelor's degree or higher in a relevant scientific quality assurance/technical field.

• 5 years’ experience in a Manufacturing environment.

• Ability to organize time for multiple tasks (major projects and daily functions).

• Good written, verbal, and interpersonal communication skills.

• Proficient computer skills, such as Microsoft Office, including Teams.

• Leadership skills: Building the best team, business insight, strategic mindset, problem-solving, resource management.

• 7+ years experience in a manufacturing Quality role.

Additional Skills & Qualifications

• Experience with CAPA, change control, quality assurance, Oral Dosage, Product Deviation, CDMO, and QMS.

Work Environment

Expected to work 1st shift - onsite 5 days a week with flexibility for hybrid work. The environment is fast-paced, requiring the ability to handle a large workload. Employees will be offered accrued PTO as well as holiday benefits.

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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.