Location: Jersey Shore,PA, USA
At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?
There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
Job Summary:
This position will lead global strategies and continuous improvement initiatives for Supplier, Corporate Facility and Third-Party audits, across our multiple business units to ensure all meet intended level of quality for products and services. In addition, planning and supervision of the quality systems activities including availability, audit management, customer engagement and management of the quality systems. This role will trend West Customer audits to identify continuous improvement needs for West's system and processes.
Essential Duties and Responsibilities:
* Site QA Manager designee for QA Systems and customer engagement activities.
* Prioritize & manage available QA systems resources to ensure on time scheduling and response timelines are achieved for customer audits, notifications responses, management reviews, and customer complaints.
* Ensure that identified CAPA's are implemented on time and able to effectively address the root causes of the issues.
* Manage cross functional teams to drive product quality improvement projects.
* Ensures compliance with Customer Agreements and Specifications, Applicable ISO standards and regulations.
* Manage the quality systems group to maintain ISO 15378 / 9001 compliance.
* Ensure data integrity of data generated in or housed within the quality systems. Take actions in case of gap identified in terms of data integrity.
* Participate in technology transfer activities including risk assessment, equivalency studies and part number setup.
* Support validation of facilities and equipment and process. Approve engineering studies and other protocols as required.
* Supports investigations related to Non conformances, Audit observations, CAPAs, or Issue Reviews as needed.
* Manages and support Customer and Corporate 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.
Education and Experience:
* Bachelor's degree in engineering or related technical discipline required, Master's degree preferred
* Minimum 8 years management experience required
* Certified Software Quality Engineer (ASQ CSQE) preferred
* Six Sigma Green Belt Certification preferred
Knowledge, Skills and Abilities:
* Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
* Experience Able to comply with the company's safety policy at all times
* 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
* Able to comply with the company's quality policy at all times.
Physical and Travel 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
* 20%: Up to 52 business days per year
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West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to ...@westpharma.com. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.