Manager Quality Assurance
2 weeks ago
The Manager Quality Assurance has to manage the development, establishment, and maintenance of Quality Systems, policies, processes, procedures and controls ensuring that performance and quality of cGMP documentation and records conforms to established standards and will be directly reporting to Executive Vice President Quality
Main Responsibilities:
* Manage organizational quality with established SOPs and processes (Deviations/Investigation, CAPA, Quality/Operational Risk Management, Change Control, Quality Metrics, Internal Audits, External Vendor Audits, and Inspection Readiness)
* Manage the Inspection Readiness Program and oversee the execution of regulatory audits and tracking of responses to ensure progress. Compiles all regulatory inspection observations/findings and monitor for signals and trends.
* Assist in the management and logistics of third-party inspection related activities.
* Manage the Internal and External Audit Schedules/Programs and oversee the execution of the remediation responses to ensure progress. Compiles all audit findings and monitor for signals and trends.
* Manage the Vendor Management System, which includes the vendor approval and qualification process, maintenance of the Approved Vendor List, and oversee the management for creation/response to vendor questionnaires.
* Oversee Quality Operations (incoming inspection, in-process testing).
* Drive consistent reporting of appropriate Quality Management System and other applicable metrics.
* Establish and monitor quality metrics for GMP related functional areas within the organization. Issue monthly reports. Escalates significant issues to executive management, as required.
* Identify quality issues/discrepancies, and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner.
* Promote a quality mindset within Quality and throughout RK Pharma by ensuring consistent, risk-based, and innovative thought processes are employed to advise and make decisions.
* Communicate milestones and planned changes to the user community regarding Quality System and Compliance initiatives.
* Provide operational management for the functional team.
* Train team members and/or coordinate training for the facility including but not limited to annual cGMP training.
Knowledge, Skills & Technical Expertise:
* In-depth knowledge of aseptic processing, isolator experience a plus.
* In depth knowledge of GxP regulations. Strong knowledge of good regulatory compliance practices, policies, and procedures.
* A strong customer focus and ability to prioritize and adapt to business needs are required.
* Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
* Extensive knowledge of risk assessment strategies and tools. Ability to identify and mitigate risks.
* Extensive knowledge of investigation techniques and tools.
* Demonstrated ability to work across functions at all levels where the incumbent may not have direct authority to accomplish objectives.
* Ability to make independent sound decisions and independently manage priorities in alignment with customer and company objectives.
* Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
* Must be a dynamic, hands-on manager with a clear practical understanding of GXPs and the ability to support regulatory inspections, as required.
* Must be able to manage problems of diverse scope using a high degree of personal judgment and must be able to effectively represent RK Pharma
* Ability to effectively mentor and develop staff.
* Problem-solver with the ability to make difficult decisions under challenging circumstances.
* Excellent knowledge of best practices in manufacturing, packaging, and quality systems.
* Excellent organizational skills.
* Technical knowledge of pharmaceutical manufacturing, validation, raw materials, analytical testing, and materials management.
* Prior experience with Master Control software is a plus
Supervision:
* Work under general supervision to meet company goals
Measurement of Performance:
* Maintain a Positive, professional attitude toward work and willingness to cooperate with peers and to contribute to a project team
* Demonstrate confidence in knowledge of Good Manufacturing Practice (GMP) regulations.
* Demonstrate timeliness and accuracy in completion of projects and paperwork
* Contribute to right first time and on-time delivery of assigned projects
* Demonstrated understanding and adherence to regulatory policies, safety procedures and cGMPs
* Ability to succeed in a team-oriented environment under very dynamic conditions
Qualifications:
* Bachelor's degree in Scientific or engineering discipline required.
* Advanced scientific, technical, or business degree a plus.
* Minimum of 5-7 years of experience in cGMP and pharmaceuticals/biopharmaceuticals or related industries with a concentration in one of more of the following functions: Quality, Quality Systems, Regulatory or Regulatory Compliance.
* 3+ years managerial experience.
* Cleanroom/Aseptic Area experience required
* Must be detail oriented, conscientious and be a dependable self-starter
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