West Pharma Sr Mgr Quality Systems 

United States, Arizona, Scottsdale 

829657599

Essential Duties and Responsibilities:

• Assist in the execution Quality strategic plans and policies for Scottsdale site.
• Prepares the site for internal/external/corporate audits.
• Lead/Execute the internal auditing process.
• May lead and support the execution of external (customer and regulatory bodies)/corporate audits.
• Conduct training and re-certification as appropriate for quality and other personnel in relation to improvements of the quality system
• Recruit, train, develop, and lead staff to accomplish personal and organizational goals, adhere to policies/procedures and establish/maintain a ‘culture of quality’.
• Creates Goals and Objectives for QMS organization and development plans for the team members
• Address human resources cases as needed.
• Recommend, evaluate, and implement process changes that are designed to continually improve the quality management system (NCR, CAPA, Issue Reviews, Deviations, Doc Control, Lot Release, auditing process, Management review process, etc.).
• Assure that the Quality System is compliant with applicable Regulatory and Industry standards.
• Maintain Quality Metrics to demonstrate areas of improvement and state of compliance.
• Prepares Quality Systems Management Review (QSMR) and follow-up on action items open during QSMR.
• May lead External Standards process to ensure applicable standards are assessed for the new applicable changes.
• Generate, review or approve Quality Assurance related documentation required for customer relationship/product development (such as: development, supply and quality agreement), verification of compliance, or for filings with regulatory bodies.
• Other duties may be assigned as needed.

Basic Qualifications:

• Bachelor’s degree or equivalent experience in Engineering or Science preferred

• More than 10 years of work-related experience required with 3-5 Years of Supervisory experience.
• Must possess knowledge of regulatory and governmental guidelines and requirements (FDA: 21 CFR Part 820, ISO 13485:2016, cGMP, GLP, EU-MDR, )

Preferred Knowledge, Skills and Abilities:

• Master’s degree preferred with an emphasis in Engineering, Science, or Business.
• Strong knowledge and experience in Quality Systems in Medical Devices/Pharmaceuticals
• ASQ - CQA/CQE Certification is preferred.
• Lead Auditor certification is preferred.
• EU-MDR certification is preferred.
• Demonstrated people skills specific to team building, problem solving and conflict resolution.
• Excellent presentation, writing, verbal, computer, interpersonal and communication skills.
• Ability to adapt to frequent changes, unexpected events and still yield an effective outcome.
• Manages competing demands, makes timely and sound decisions, even under conditions of risk.
• Accepts feedback from others, ability to engender enthusiasm, motivate peers and subordinates and teambuilding.
• Effectively influences actions and opinions of others. Ability to perform effectively and efficiently in a fast-paced environment.
• Ability to assess procedures, policies, work instructions and site forms to improve processes and Quality Systems
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

Travel Requirements:

• Must be able to travel up to 10% of the time

Physical & Mental Requirements:

• Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics.
• Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition.
• Must work constructively in an environment that may have competing resources while at all times maintaining company confidentiality.
• Must be able to work scheduled work week, plus overtime and/or irregular hours as required to complete assignments.
• May stand or sit for extended periods of time.
• Must transport oneself to and from other areas of the facility and travel to other facilities when necessary.
• Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues.