Director Of Quality Assurance

POSITION SUMMARY:Manages activities of the Quality Assurance department and responsible for implementation and maintenance of quality systems.ESSENTIAL DUTIES AND RESPONSIBILITIES:Responsibilities include, but are not limited to:•Provide leadership and direction for the CMC QA activities to ensure attainment of corporate objectives•Manage the quality system and support/oversight of suppliers, vendors, and contract manufacturing organizations, including the external auditing of external suppliers and partners in addition to the internal audit program.•Compile all investigations and audit findings and monitor for signals and trends.•Prioritize and communicate findings and escalate significant issues to Supervisor.•Identify emerging quality issues and reports to Supervisor.•Responsible for ensuring that quality systems are deployed and maintained in accordance with cGMP, GCP, GLP, policies, standards and SOPs.•Responsible for implementing and maintaining the company's continuous improvement efforts.•Responsible for reporting and monitoring comprehensive quality metrics.•Facilitate remediation efforts and identify and communicate opportunities for improvement.•Maintain thorough knowledge of company's systems, utilities and other tools.•50-70% of time consumed with QA; 30-50% to be other projects as assigned by SupervisorYEARS OF EXPERIENCE:At least 5-7 years of pharmaceutical industry experience.PHYSICAL REQUIREMENTS / WORKING CONDITIONS of POSITION:The employee is frequently required to stand; walk; reach with hands and arms; stoop, kneel, or crouch and talk or hear. The employee may be required to sit for long periods of time. The employee must be able to lift and/or move up to 10-15 poundsOTHER SKILLS AND ABILITIES:•In-depth knowledge of GxP, 21 CFR, QSR, ICH, EU GMP, ISO and other applicable international regulations, standards, Directives and Guidance's.•Excellent communication and leadership skills to effectively promote and manage change.•Excellent leadership skills with the ability to coach, mentor and develop staff.•Strong negotiation, influencing and conflict resolution skills.•Ability to educate stakeholders, customers and management.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 talentMaintaining an inclusive environment through persistent self-reflectionBuilding a culture of care, engagement, and recognition with clear outcomesEnsuring 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.