Director, Technical Quality & Compliance

Johnson Johnson; Bogotá ciudad; Presencial; COP 120.000.000 - 180.000.000; Jornada completa

Descripción de la vacante

Johnson & Johnson is seeking a Director, Technical Quality & Compliance to lead regulatory activities for medical devices and other products. The role focuses on governance, data integrity, and global compliance across the product lifecycle.

The position requires extensive experience in GMP, CSV, and quality systems, with the ability to influence senior leaders and drive transformation in a complex, matrixed organization.

Formación

• 10–12 years of experience leading GxP computerized systems validation (CSV).
• Deep understanding of global cGMP regulations and data integrity concepts.
• Experience in medical devices/pharma regulated environments preferred.

Responsabilidades

• Ensure J&J quality standards and global regulatory requirements are met.
• Lead validation lifecycle management and SDLC governance.
• Provide TQ&C leadership to project teams and cross-functional partners.
• Drive timely delivery of compliant, high-quality systems within budget.

Conocimientos

GxP CSV

Regulatory compliance

Leadership

Descripción del empleo

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Quality

Job Sub Function: Quality Systems

Job Category: Professional

All Job Posting Locations:

Bogotá, Distrito Capital, Colombia, Palm Beach Gardens, Florida, United States of America, Raritan, New Jersey, United States of America, Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

DePuy Synthes is recruiting for a Director, Technical Quality & Compliance, located in Bogotá or Palm Beach Gardens or Raynham or West Chester or Raritan.Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Job Overview

The Director, Technical Quality & Compliance, provides strategic leadership for Medical Device Regulatory activities. This role ensures the integrity, governance, and effective use of regulatory data to support compliance, regulatory submissions, and informed decision‑making across the product lifecycle. The position plays a critical role in strengthening regulatory capabilities, enabling digital transformation, and supporting global regulatory readiness within DePuy Synthes.

Key Responsibilities

• This role must ensure that all J&J quality standards and global regulatory requirements are being met
• This role ensures that building and execution activities include early involvement of quality in the design and development activities, building quality into the work product, building controls within the application/solution, and use of automation whenever feasible
• The role provides TQ&C expertise/guidance to the project teams
• This individual must drive the implementation and maintenance of systems to be delivered on time, within budget and with high quality
• This individual must provide end-to-end Technology Quality leadership support to projects and base business support teams across applications and cloud infrastructure
• This individual will lead the quality approach for systems and ensure teams are accountable for delivering on an end-to-end support model for systems in scope
• Partners with Regional Leads in support of the TQ&C Operating Model
• This role will lead global teams with unique skills in cross-functional environments.
• This role will provide an environment which encourages the company's credo and the value of a diverse workforce
• This role serves as a trusted partner across the Technology Quality & Compliance organization, requiring collaboration skills at the senior leadership level, both internally and externally

Experience and Skills:

Required:

• 10-12 years of experience leading GxP computerized systems validation (CSV) within pharmaceutical, medical device, biotech industry, or other regulated industries.
• Deep understanding of GxP regulations and compliance requirements, including data integrity, SDLC governance, validation lifecycle managements, electronic records/signatures, audit trails, and inspection readiness.
• Thorough knowledge of global cGMP regulations and computerized systems requirements including:

Preferred:

• Experience in medical devices, healthcare, or other highly regulated industries.
• Experience working in global, matrixed organizations.
• Familiarity with electronic quality management and training systems.
• Demonstrated success driving quality system transformation or harmonization initiatives.
• Quality or Regulatory certifications (e.g., ASQ, RAC).
• Excellent analytical, communication, and change‑manag