IT Quality Manager, INFOSEC

Driven by the passion to improve quality of people's lives, WS Audiology continues to grow as market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want to accelerate our business transformation to reach more people, more effectively.

We are looking for a IT Quality Manager who is responsible to oversee all IT quality activities to comply to the regulation ISO 13485 and 21 CFR part 11 including ensuring the system is validated prior to usage and all changes are tracked and able to trace back to the original intended use of the software. All policies and procedure related to Quality Management System within IT is governed by this role as well.

The role will be imperative in a regulated environment (medical device industry) whereby stringent check and audit is regularly done to ensure patient safety, product quality and regulatory compliance.

What you will Do

• Leading and overseeing the validation lifecycle of GxP-relevant computer systems and software used across the organization. This includes planning, coordinating, and executing validation activities to ensure systems are compliant with applicable regulations and internal policies such as FDA, 21 CFR Part 11, ISO 13485, GAMP 5, internal WS Audiology quality management requirements, and other relevant compliance guidelines
• Managing Stakeholder and collaborate to ensure alignment on computer system validation is adhered and provide consultancy if there is a need to elaborate and guide them.
• Prepare status report with the help of team member to meet audit requirements (e.g. FDA, TUEV, GMP, ISO, KPMG, PwC etc.), periodically in every quarter/month/bi-yearly.
• Manage Team Members and growth for their career development. Becomes coach and mentor for the team member.
• Conduct IT compliance assessment on systems, infrastructure, procedures, and work instructions.
• Ensure requirements and architecture designs undergo reviews to proactively validate appropriate applicability, accuracy, feasibility, usability, clarity, and testability.
• Ensure that templates such as protocols and reports are created and maintained in accordance with validation process, based on the principles of GAMP and other relevant compliance needs.
• Participate in project work on software validation and process validation.

What you bring

• Minimum 7 years of experience in Computer System Validation in medical device or pharma industry and have a good background in software development life cycle such as waterfall methodology and/or Agile methodology.
• Familiar with Good Documentation Practice framework
• Experienced in managing IT General Control audit activities with internal and/or external auditor
• Familiar with GxP regulations such as GAMP 5, CFR 21 part 11, data integrity principle

Leadership / management experience:

• Comfortable working with people from various level of management, from operational and working level to senior management level. Able to work alone with minimum supervision/guidance.
• 3 years in managing team or has at least 2 direct report

Education:

• Bachelors/master's degree in information technology or computer science combined with Computer System validation certification or related discipline.

Industry experience:

• Track record as contributor in providing computer system validation / audit support in managerial capacity.
• 5-10 years of medical device or Pharmaceutical industry exposure
• Other relevant minimum requirements:
• Familiarity with systems like ERP, LIMS, MES, CDS, QMS, etc.

Who we are

At WSA, we provide innovative hearing aids and hearing health services.

Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world.

With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes.

Sounds wonderful? We can't wait to hear from you.

WSA is an equal-opportunity employer and committed to creating an inclusive employee experience for all. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status we firmly believe that our work is at its best when everyone feels free to be their most authentic self.