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Applied Materials Pharma QA/QMS Lead Engineer in Newburyport, Massachusetts

The role of the APG Pharma Groups Software QA Lead is to ensure delivery of the SmartFactory Rx suite of applications according the quality management system guidelines as set forth by the QA Manager.

General Profile

To provide leadership of Pharma engineering quality assurance team and support the software developers to assist in implementing quality through the product lifecycle. To assist in the construction and implementation of a quality management system including testing and validation that will be accepted by customers and regulators of the Pharma industry.

Key Responsibilities

  • Leads QA and R&D with governance on validation (including 3rd Party) and regulatory adherence to: 21CFR11, GAMP 4/5, EU Annex 11, ISO 9000/5000/15000.

  • Leads QA with governance of Pharma SDLC (Software Design Life-Cycle) process.

  • Develop and execute testing engineering plans and manage QA testing schedules and resource allocation and budget Provides technical leadership to team members to achieve project goals.

  • Supports technical sales as needed for quality program representation.

  • Supports Pharma business for internal and external audits.

  • Demonstrates broad and comprehensive understanding of technical and business environment.

  • Develops and articulates strategies to meet business objectives.

  • Ensures Product release requirements and documentation/packaging are met.

  • Conducts broad and comprehensive analysis of key industry trends, regulatory and technology to assist in the validation of GMP software Interfaces and coordinates with internal customers (SW, HW, PO) to define project objectives, provide status updates and prepare for release and deployment.

  • Manages employees (direct reports, contract, or matrixed reports); contributes to effective performance management, employee development and retention.

  • Develops personnel to include training and career development, manages the performance management process to include the development of team and individual goals, implementing employee development plans and coaching.

  • Participates in, and/or manages, employee selection and hiring of personnel.

  • Manages reward and discipline processes.

  • May also select and manage Professional Services and outsourced staff.

  • Takes major part in cross agendas (standardizations, tools, methodologies, KPIs) and building long term strategy.

Qualifications

  • Bachelor's Degree (Computer Science or Engineering) or equivalent

  • Years of Experience: 5-8 Years in Computer Software Validation and/or QA

Travel: Yes, 20% of the Time

Location: Remote or office based

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Qualifications

Education:

Bachelor's Degree

Skills

Certifications:

Languages:

Years of Experience:

1 - 2 Years

Work Experience:

Additional Information

Travel:

Yes, 10% of the Time

Relocation Eligible:

Yes

Applied Materials is an Equal Opportunity Employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, national origin, citizenship, ancestry, religion, creed, sex, sexual orientation, gender identity, age, disability, veteran or military status, or any other basis prohibited by law.

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