Job Summary - a concise overview of the job
The Senior Quality Specialist will have a portfolio of responsibilities that cover Global Quality processes in addition to local / site based Quality responsibilities.
The global responsibilities include facilitating global governance committees for the enterprise Document Management and Quality Management systems and processes. As the facilitator, run the governance model, which includes managing business user requests, prioritizing, and working closely with system administrators for scheduling and delivery of quarterly releases. Additionally, this person will be part of efforts to enhance and introduce global processes, and then be on point to include in the Governance models.
The local responsibilities include being the primary Quality Assurance (QA) lead for commercial GxP activities for the Malvern, PA location. This includes but is not limited to Document Management activities, overseeing Training Curriculums, conducting Vendor Qualifications, and delivering periodic audit reviews to direct Manager and Senior Management.
This role will also be responsible for providing oversight and support to site validation initiatives. This includes but is not limited to supporting the development of Quality IT system validation testing processes and associated documents, and providing user training and support as required for the identified system(s). This role acts as lead Quality Reviewer on assigned / approved projects, which includes maintaining a monthly portfolio scorecard reporting status of all site validation activities.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Works independently or within a cross functional team as required.
Acts as primary QA lead for all Malvern QMS activities; reviews proposed changes, recommends any needed enhancements, maintains the data quality within the system for their site.
Facilitate global governance committees for enterprise systems for the implementation of enhancements and best practices.
Participates on and provides QA direction to cross-functional teams and validation efforts as assigned by management.
Resolves Quality / Validation Issues that fall within areas of job responsibilities.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
Quality IT Systems
Supports Quality IT Systems projects as required.
Establishes best practices for the control and maintenance of Quality IT systems.
Provides QA oversight and participates in the development of validation documentation and execution as needed.
Facilitate global governance councils for enterprise Quality systems to evaluate business user changes and the introduction of new functionality for the company.
Works with system administrators to develop required change(s), identify required testing to maintain a system's state of validation and execute delivery of the change(s) within identified timeframe.
Monitors the performance of the sites QMS process and provide metrics to management as required.
Provide QA direction and support to Malvern commercial GxP activities.
Collaborates with cross-functional departments to resolve complex Quality issues at the Malvern site.
As directed by Management, develop approaches to strengthen Compliance profile and/or framework for Malvern site
Develops and maintains training curricula for the IT QA department and Malvern site Commercial GxP activities.
Participates as QA representative on cross-functional training teams for the development of site GMP curricula.
Creates and maintains training knowledge assessments as needed.
Backs-up department/site training coordinator as required.
Resolves business user questions and issues related to the enterprise Electronic Document Management processes.
Resolves business user questions and issues related to the enterprise Quality System processes.
Provides Subsystem support for identified systems and end users.
Creates, Modifies and executes training programs to support local and enterprise systems as required.
Escalates system issues and works with IT or the vendor directly to resolve.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
BA/BS or equivalent relevant experience.
Minimum of 6 years' experience working in a Quality role in a GXP environment in the pharmaceutical or medical device industry.
At least 1 year of experience using electronic documentation to process and maintain documents is preferred.
Experience with regulatory authority inspections preferred, but not required
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
Demonstrates an understanding of fundamental GxP terminology, concepts, regulations and industry standards.
Knowledge of records and data management systems/processes and tools.
Demonstrates a thorough understanding of change control process and associated regulatory requirements and their application.
Knowledge of Good Documentation Practices required.
Knowledge of Computer System Validation approaches.
Often referred to as "competencies", leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
Proficient in Microsoft Office suite of tools.
Strong technical acumen and experience with utilizing industry Quality systems.
Strong attention to detail.
Strong technical writing skills in addition to strong command of general grammar and usage principles.
Demonstrates excellent interpersonal skills.
Ability to establish and maintain effective working relationships with customers; gain trust /respect and ensure service levels are maintained; and ensure cGMP compliance and adherence to established procedures.
Ability to effectively communicate using a variety of styles to ensure that service levels are maintained.
Plans, prioritizes, and negotiates concurrent assignments and completes within agreed upon timeframe.
Ability to identify and troubleshoot routine technical problems.
Ability to work collaboratively on project teams.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job.
They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.