Director, Quality Control at Johnson & Johnson

Gurabo, Puerto Rico, Puerto Rico

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, MedTechIndustries

Requirements

Necessary education, training, and experience to fulfill QC job duties and responsibilities (for all personnel, implied leadership capability)
Ability to lead and build a high-performing QC team, including hiring decisions, staffing, training, coaching, mentoring, and performance management aligned with J&J Leadership Imperatives: Connect, Shape, Grow
Expertise in laboratory operations, regulatory compliance (cGMP, GxP, EHS), and data integrity to provide guidance and support inspections/audits

Responsibilities

Lead all QC laboratory operations, including chemical, microbiological, and physical testing of raw materials, packaging, in-process, final product, and stability samples
Ensure full compliance with EHS and GxP standards, regulatory requirements, and internal procedures
Develop and implement strategic plans to support technology transfers, product launches, and continuous improvement initiatives
Serve as a key contributor to site and regional leadership teams, representing QC in cross-functional and global forums; collaborate with peer Lab Leaders on local, regional, and global projects
Drive performance metrics such as on-time testing, right-first-time results, and operational efficiency
Ensure timely closure of investigations, CAPAs, and change controls related to laboratory operations
Maintain GMP-compliant laboratory facilities, equipment qualification, calibration, and cleanliness; provide direct support to internal audits, regulatory inspections, and Escalation meetings for QC-related issues
Conduct quality risk assessments and support resolution of customer complaints
Build and lead a high-performing QC team, including Managers and Supervisors; make hiring decisions, ensure staffing levels, and provide training/development
Develop a clear talent strategy for technical and leadership growth within the QC function
Coordinate budgeting, resource planning, and cost forecasting for operational and capital expenditures; approve high-value purchases aligned with financial controls
Review and approve QC data, protocols, procedures, and technical reports
Provide expert guidance on laboratory operations, regulatory compliance, and data integrity
Support global QC initiatives and collaborate with peers

Skills

Key technologies and capabilities for this role

cGMPQuality ControlLaboratory OperationsChemical TestingMicrobiological TestingPhysical TestingRegulatory ComplianceContinuous Improvement

Questions & Answers

Common questions about this position

Is this a remote position or does it require on-site work?

The position is located in Gurabo, Puerto Rico, and requires on-site presence as part of the site leadership team.

What are the key responsibilities of the Director, Quality Control role?

The role involves leading all QC laboratory operations including chemical, microbiological, and physical testing, ensuring compliance with cGMP and regulatory standards, developing strategic plans, and driving performance metrics like on-time testing and operational efficiency.

What skills and experience are required for this position?

Candidates need expertise in leading laboratory operations, ensuring compliance with cGMP, GxP, and regulatory standards, strategic planning for QC, and experience with quality risk assessments, investigations, CAPAs, and cross-functional leadership.

What is the company culture like at Johnson & Johnson for this role?

The role cultivates a culture of excellence, innovation, and continuous improvement, with collaborative work across site, regional, and global teams to drive value in the J&J Supply Chain.

What makes a strong candidate for the Director, Quality Control position?

A strong candidate is a visionary leader with proven ability to lead QC labs, align strategic goals with site and global objectives, ensure regulatory compliance, and contribute to cross-functional teams in a pharmaceutical manufacturing environment.

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

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