Quality Assurance Manager - Validation

Job Description

Job Description

Quality Assurance Manager - Validation Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. This position will report into the Associate Director of Quality Assurance responsible for the oversight and management of Quality Assurance Validation/Qualification activity. Responsible for managing the quality assurance validation activity such as development, implementation, and continuous improvement initiatives at two Allendale, NJ manufacturing sites. This role works to build, enhance, harmonize and manage quality assurance validation across sites and is responsible for finding solutions and coordinating change initiatives. Core responsibilities include, but not limited to, document management: review and approval of validation protocol, report, investigation report, assignment of CAPA, SOP development and revisions. Provides cross departmental support within Quality Assurance, as well as, collaborates with other Quality departments to support organizational and functional strategy. Develops and/or revises policies and procedures, as well as, supports operational excellence initiatives. Represents Quality Compliance in internal and external audits which may include interaction with regulatory health authorities and clients.

• Functions as the sites Quality Assurance validation partner ensuring quality standards are enforced.
• Partners closely with quality training staff in development of learning curriculum that drives compliance standards.
• Oversees and manages the activities of validation team; provides leadership and direction to ensure that organizational and departmental goals are met.
• Coordinates the investigation and closure of deviations with root cause analysis.
• Ensures appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented.
• Manages end-to-end delivery of quality document assuring compliance of company's quality standards.
• Reviews and approves GMP documents such as investigation report, CAPA, validation protocols and reports, SOPs, change controls, etc.
• Reviews and proposes changes to quality agreements.
• Participates in ongoing quality system improvement programs and initiatives. Establishes Quality Validation KPI Reporting and Continuous Improvement metrics.
• Participates in internal audits, regulatory agencies, and client audits.
• Provides technical information during tech transfer activities to ensure all quality requirements are met according to current industry standard.
• Establishes departmental KPIs in alignment with organizational goals and objectives.
• Plans and allocates resources to effectively staff and accomplish the work to meet departmental productivity and quality goals.
• Plans, evaluates, and improves the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output.
• Makes business decisions that are financially responsible, accountable, justifiable, and defensible in accordance with organization policies and procedures.
• Establishes and maintains relevant controls and feedback systems to monitor the operation of the department.
• Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees.
• Provides oversight and direction to the employees in accordance with the organization's policies and procedures.
• Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities.
• Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback.
• Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise.
• Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization.
• Leads employees to meet the organization's expectations for productivity, quality, continuous improvement, and goal accomplishment.
• Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning.
• Provides effective performance feedback through employee recognition, rewards, and disciplinary action, with the assistance of Human Resources, as necessary.
• Maintains employee work schedules including assignments, job rotation, training, vacations and paid time off, coverage for absenteeism, and overtime scheduling.
• Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, Instant Messaging (IM), and regular interpersonal communication.
• Supervise 1-2 Direct Reports
• Other duties as assigned.

REQUIRMENTS

• Bachelor of Science in biological sciences or other relevant field of study.
• 5-10 years’ relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments. 3+ years of recent supervisory experience required. Experience in both clinical and commercial manufacturing is preferred.
• Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis.
• Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
• Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (investigation, validation/qualification reports, SOPs etc.)
• Experience in organizing and leading teams.
• Experience participating in health authority inspections and/or client audits.
• Ability to think strategically and tactically (detail-oriented)
• Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
• Analytical and problem-solving skills
• Strong written and oral communication skills
• Meeting management/facilitation skills/teamwork
• Ability to multi-task team is essential
• Flexible and able to adapt to company growth and evolving responsibilities.
• Training; GXP, SOP & WI training, Safety
• Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit.
• Must be able to foster and work in a team-oriented environment.
• Must be able to work infrequently on weekends, nights, and/or holidays as required/necessary.
• May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids.
• Must be able to handle the standard moderate noise of the manufacturing facility.
• Must be able to work in open floor plan environment and may work in close proximity to others.
• Wheel-O-Vator available for use.
• Small breakroom available. No on-site cafeteria available.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.