[Close] 

Associate Director, Quality Assurance

The Associate Director will lead key compliance projects for Laboratory Operations aimed at elevating the compliance posture. As a Project Manager, the individual is expected to fully manage all aspects of assigned projects, including but not limited to: quality decision making, stakeholder management, issue identification and resolution, and driving all aspects of the project in alignment with established timelines. Maintains strong quality management systems to actively ensure compliance while striving to optimize Quality Operations within the Laboratory. Actively participates in the Tier process, as appropriate, and uses this forum to escalate concerns and best practices. Responsible for the Quality oversight and classification / approval of investigative events in Laboratory Operations. Performs review and approval for CAPAs, QCTS commitments, change requests, investigative protocols and final reports. Performs review and approval of IQ/OQ/PQ documents for assigned laboratories of responsibility, as needed. Provides Quality consult to Senior Quality Specialists performing monthly internal audits of laboratory areas. Reviews and approves Standard Operating Procedures, Controlled Job Aides, Control Procedures, Quality Standards, etc. Provides coaching and guidance to new personnel and to Quality Specialists and Sr. Quality Specialist colleagues. Provides support to Regulatory Agency inspections as needed. RMT Lab Table, Facilitator/Minute Taker with inspector, minute taker on tour, Doc Room Lead, Doc Room Person, RMT Lead  Proactively partners with Laboratory Operations and Laboratory Technology personnel to ensure that all process improvements and capital projects are timely, robust and in alignment with corporate goals.  Qualifications Education: Bachelor's degree in science, engineering, or related areas of study. Required Experience and Skills: For candidates with a Bachelor's degree, a minimum of 5 years of experience in GMP Manufacturing environment, Pharmaceutical / Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.  For candidates with a Master's degree, a minimum of 3 years of experience in GMP Manufacturing environment, Pharmaceutical / Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting. Preferred Experience and Skills: In-depth working knowledge and application of GMPs/GLPs Progressive and demonstrated Quality decision making responsibility Project Management, Change Execution Management and Team Leadership experience in a Quality function. Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment. Demonstrated self-starter with capability to develop innovative solutions to challenges. Demonstrated facilitative leadership skills and able to lead cross-functional project teams to deliver results. Proven analytical aptitude, critical thinking skills and ability to apply key concepts. Speaks with courage and candor. Strong written and verbal communication skills. Proven ability to manage multiple projects simultaneously. Experience in pharmaceutical laboratory operations or related environment. MAN005996
Salary Range: NA
Minimum Qualification
5 - 7 years

Don't Be Fooled

The fraudster will send a check to the victim who has accepted a job. The check can be for multiple reasons such as signing bonus, supplies, etc. The victim will be instructed to deposit the check and use the money for any of these reasons and then instructed to send the remaining funds to the fraudster. The check will bounce and the victim is left responsible.