West Pharma Quality Systems Compliance Manager 

United States, North Carolina 

605302108

:

Essential Duties and Responsibilities:

• Manage all audit related activities for West’s Audit program which includes supplier, corporate facility, and third-party audits.
• Perform corporate facility audits of West’s sites to ensure compliance with procedures and applicable standards and regulatory requirements.
• Perform audits of West’s suppliers to assess their Quality Management System, and ability to meet West’s quality standards, and applicable regulations. Provide Audit support for supplier selection process for new product development and procurement second sourcing strategies.
• Develop and manage global strategies for standardized audit processes, audit tools, and audit plans and ensure use in all audit activities.
• Manages and supports post-audit activities and follow-up on any necessary corrective and preventive actions; resolves any conflicts.
• Manage global audit schedule(s); Partner with key stakeholders to develop risk-based audit planning. Evaluate executed audits, including customer audits, to define current quality trends identified as risks/issues and determine impact on global quality systems and initiate actions, as needed.
• Manage global relationship and activities of West’s third-party audit providers; Establish expectations and ensure Third Party audit providers perform as expected.
• Establish and manage Auditor matrix which identifies trained auditors and areas of expertise; Enhance auditor training program to include specific trainings to expand auditor expertise and increase auditing capabilities. Establish processes and tools to increase visibility of audit and audit findings in a standardized format to West leadership.
• Support the ongoing update of the QMS in line with emerging issues or changes to regulatory expectations.
• Collaborate with Supplier Quality Management to ensure alignment with supplier risk mitigation strategy and communicate on audit program priorities.
• Generate, review, or approve Quality Assurance related documentation required for product.
• Other duties as assigned.

Basic Qualifications:

• Bachelor's Degree in Engineering or related technical discipline required
• Master's Degree preferred

Work Experience:

• Minimum 8 years (Mgr.) related experience required

Preferred Knowledge, Skills, and Abilities:

• Experience in regulated industry such as pharmaceutical and medical device.
• In depth knowledge of cGMP, cGDP, relevant ISO standards and medical device requirements.
• Experience with SAP systems
• Familiarity with document management databases, particularly MasterControl
• Use written and oral communication skills. Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making
• Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of customer visits and business development related activities.
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze, and solve problems

Licenses and Certifications:

• Certified Software Quality Engineer (ASQ CSQE) preferred
• Six Sigma Green Belt Certification preferred

Travel Requirements:

• Estimated Amount 20%
• Up to 52 business days per year

Physical Requirements:

• Sedentary exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.

Additional Requirements:

• Adaptable to changes in the work environment, able to manage competing demands and deal with frequent change, delays, or unexpected events.
• Must maintain the ability to work well with others in a variety of situations.
• Maintain high attention to detail, accuracy, and overall quality of work.
• Must be able to understand and adhere to established procedures, multi-task, work under time constraints, problem solve, and prioritize.
• Effectively communicate and interface with various levels internally and with suppliers.