Associate Director, Quality Operations
The Quality Operations Associate Director (QOAD) is accountable for providing quality direction and oversight to West Point B62 and B56 warehouse operations and execution and performance within the systems of Quality oversight such as Internal Auditing, Training, Change Control, Inspection Management, Deviation Management and Risk Management, in order to maintain compliance with Regulatory requirements.The individual is an Advocate for the development, execution and deployment of the West Point Site, Vaccine Quality, and Manufacturing Division priorities. The Associate Director drives quality improvement activities and ensures alignment across the execution of their assigned areas and is accountable for the development and maintenance of Quality Systems in particular the execution of Materials Management, Distribution, and Management of Returned Goods in accordance with cGMPs, international regulations and our Company Quality Management systems, policies and procedures.The successful candidate manages a team responsible for the release of all components and raw materials that support downstream customer needs for vaccine manufacturing and will guide their team in quality decision making and support the development of personnel through effective coaching and feedback and by modeling inclusive behaviors. In order to effectively manage Quality Operations within the IPT, the QOAD must demonstrate excellent leadership abilities with strong quality decision making, problem solving, and collaboration with their Operations and Technology leads. IPT Quality Operations Leader also participates in regulatory inspections and is a member of the IPT Leadership Teams and the E2E SS&IM Quality Leadership Team. Additional Responsibilities Maintains strong quality management systems to actively ensure compliance while striving to optimize Quality Operations Actively participates in the Tier process, as appropriate, and uses this forum to escalate concerns and best practices Serves as an Ad Hoc member of the West Point Site Quality Council Responsible for the Quality oversight and classification/approval of investigative events Provides guidance to Senior Quality Specialists conducting reviews/approvals of investigative events Provide input on recommended CAPAs, as appropriate Completes review and approval for CAPAs, QCTS commitments, change requests, and investigative protocols and final reports Initiates and completes review and approval of IQ/OQ/PQ documents for assigned areas of responsibility Provides Quality consult to 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 Actively support to Regulatory Agency Inspections Proactively partners with Operations and Technology personnel to ensure that all key performance metrics and process improvements are timely, robust and in alignment with corporate goals Education Bachelor degree in Life Sciences or Engineering discipline, with five years minimum in Pharmaceutical Quality, Technology or Operations, Regulatory, or related experience with progressive responsibility Required Prior people management experience with emphasis on personnel development Quality Systems knowledge Project Management, Change Execution Management and Team Leadership experience Interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment Independent and Collaborative with capability to develop innovative solutions to opportunities Facilitate management skills and able to lead cross-functional project teams to deliver results Proven quality aptitude, critical thinking skills, and ability to make critical decisions Speaks with courage and candor Principled written and verbal communication skills In-depth working knowledge and application of GMPs Proven ability to manage multiple projects simultaneously Preferred Minimum three years in a supervisory/management capacity Previous experience in Pharmaceutical, Biologics, Vaccines, or Therapeutic Protein manufacturing Demonstrated proven leadership experience with domestic and international regulatory agencies in a compliance/inspection setting Risk Management tools and methodologies such as:
FMEA, PHA, Risk Rank and Filtering, Risk reporting, etc. Deviation Management experience Technical understanding of Biologics, vaccines and small molecules business Direct floor manufacturing
Salary Range:
$80K -- $100K
Minimum Qualification
Quality Management, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
FMEA, PHA, Risk Rank and Filtering, Risk reporting, etc. Deviation Management experience Technical understanding of Biologics, vaccines and small molecules business Direct floor manufacturing
Salary Range:
$80K -- $100K
Minimum Qualification
Quality Management, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
