West Pharma Senior Manager Quality Assurance 

United States, Pennsylvania, West Whiteland Township 

120209258

Job Summary:

Manage and lead the Quality Operations at the Exton, PA facility and Waterford, IE facility for the Analytical Laboratory Services. Host customer and regulatory audits, coordinate the responses to customer audit observations, customer complaints and request for information / documentation. Assure compliance with West Quality Management System and all applicable regulatory and ISO requirements.

Essential Duties and Responsibilities:

• Act as the primary interface with the customer and all regulatory agencies regarding all quality related questions, concerns or inquiries.
• Participate in customer, ISO, Corporate QA, and Regulatory audits/inspections of the West Lab Service facilities.
• Ensure Quality System is in place per West policies and procedures, and the system is in compliance with ISO standards, GMP and regulatory/compendial.
• Develop, implement, maintain and continually improve the West QMS.
• Responsible for conducting the Quality Management Review meeting per procedure
• Maintain information / statistics for assigned areas, for inclusion in the regular Management Review.
• Assure execution of internal quality audits, according to established procedures for the assigned areas / locations.
• Provide response to audit observations, and customer complaints and inquiries.
• Management of Quality personnel to ensure QMS procedures and policies are followed
• Participate in Validation Master Plan and protocol elaboration, approval and ensure that the requirement is followed and executed accordingly.
• Conduct root cause analysis and issue appropriate corrective action when deemed necessary.
• Assure investigations, CAPA, change control, calibrations are conducted, documented, and where applicable, trended appropriately
• Review / approve OOS investigation reports and any other lab investigations as deemed necessary
• Prepare, review and present the lab metrics, KPIs and reports to the management. Identify trend and define opportunities for improvements.
• Work/interface with Lab Operations personnel in the assigned areas for continuous improvements related to CAPA and / or customer or regulatory requirements.
• Review documentation for compliance to West policies and procedures, cGMPs and applicable ISO standards.
• Review and approve Laboratory procedures and work instructions.

• Performs other duties as assigned based on business needs.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Other duties as assigned

Basic Qualifications:

• Education or Equivalent Experience: Bachelor's in scientific discipline preferred. Applicable work background and experience may be considered as a substitute. Masters is a plus.

• Experience: 10+ years of experience

Preferred Knowledge, Skills and Abilities:

• Solid experience in quality
• Knowledge of ISO 9001, ISO 15378 and ISO 13485
• Experience with customer interface and meeting customer expectations.
• Working knowledge of pharmaceutical and medical device industry requirements
• Knowledge of cGMP requirements and ISO standards
• Attention for details and deadline driven
• Ability to communicate professionally
• Experience leading regulatory inspection (FDA, MHRA, etc) and requests
• Ability to work independently, effectively prioritize and escalate issue and multi-task

Travel Requirements:

• 10% travel may be required due to site responsibility (Ireland)

Physical & Mental Requirements:

• Position operates in a professional office environment and laboratory. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. May need to stand or sit for extended periods of time
• Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to multi-task, work under time constraints, problem solve, and prioritize
• Use written and oral communication skills
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger and reach with hands and arms