高级质量与合规专员

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
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Job Function:
QualityJob Sub Function:
Quality AssuranceJob Category:
ProfessionalAll Job Posting Locations:
Remote (US), West Chester, Pennsylvania, United States of AmericaJob Description:
Johnson & Johnson is currently recruiting for a Senior Quality & Compliance Specialist! This role can be performed fully remote throughout the US. Remote work may be considered on a case-by-case basis and if approved by the business.
Position Summary:
The Senior Commercial Quality Specialist is responsible for the development, execution and oversight of Quality and Compliance (Q&C) programs for the orthopedic last mile operations network within the United States. This may include internal and external orthopedic last mile Field Inventory operations, Loaner Sites, and Distribution Centers (DC) supporting delivery of Field Inventory & surgical loaner sets to orthopedic customers across the US.
This position resides in the DePuy Synthes Commercial Quality Major Markets Organization. This position collaborates with and serves as a liaison between Quality, Supply Chain, Deliver, Sales and Commercial partners on distribution and commercial quality related matters to drive timely resolution of quality related issues. This position identifies and supports implementation of improvement opportunities consistent with DePuy Synthes business objectives and applicable regulations.
The Senior Quality and Compliance Specialist initiates and supports proposals and programs designed to ensure effective and consistent processes with established standards by performing the following duties personally or through work stream groups.
Key Responsiblities:

• Define, implement, and validate quality requirements and systems to meet departmental strategies.

• Serve as single point of contact for assigned operations.

• Host and lead audits, inspections, investigations, and remediation activities.

• Ensure the Quality program maintains regulatory compliance.

• Provide quality support for existing and new distribution processes and go to market models.

• Development, implementation and review of standard operating procedures.

• Establish and maintain relationships with orthopedic last mile operations and Franchise customers to solve problems and meet changing competitive and regulatory environments.

• Be a change agent.

Execute and improve systems/processes in the following areas:

• Inspection readiness

• Process changes

• Validation, Calibration and Preventive Maintenance systems, as applicable

• Delivery service issues.

• Nonconformance investigation and corrective action plan development, implementation and effectiveness monitoring.

• Coaching and mentoring other functional areas in the areas of ISO and cGMP requirements as needed.

Qualifications:

Education:
A minimum of a Bachelors or equivalent University degree is required.
Experience:

• 6-7years of relevant work experience in a regulated healthcare, medical device, pharmaceutical, consumer products, distribution, commercial quality, or quality systems environment.

• Working knowledge of applicable FDA regulations CFR 820, ISO 13485, ISO 9001, and quality system requirements relevant to medical devices, commercial distribution and field inventory environments.

• Experience supporting quality systems, document control, training compliance, quality metrics, audits, nonconformance management, corrective action processes, or related compliance activities.

• Experience using quality system IT platforms such as Windchill, ETQ, DMS, LMS, QEM, Summit, change control systems, ERP systems, warehouse management systems, or related tools preferred.

Required skills and certifications:

• Communicate and collaborate effectively with cross-functional partners.

• Follow established procedures, complete assigned work accurately and on time, maintain organized records, and escalate issues when needed.

• Apply critical thinking, problem-solving, and root cause analysis to support issue resolution.

• Demonstrate working knowledge of standard quality system requirements, good documentation practices, technical writing, Nonconformance, CAPA .

• Use Microsoft Office, data analysis and quality system applications

• Preferred experience with Windchill, ETQ, Summit, ERP or warehouse management systems.

• Preferred experience includes audit preparation, inspection readiness, regulatory responses, or health authority interactions.

• Preferred certifications or training include Lean, Six Sigma, 5S, ASQ, ISO-13485, Good Distribution Practices, supplier quality, or other quality improvement methods.

Other:
This position may require up to 25% domestic & international travel.
EXTERNAL AND INTERNAL INTERACTIONS:
This role is responsible for internal and external support and interacts closely with the various DePuy Synthes orthopedic last mile Operations, including the Sales Organization, Supply Chain, Field Sales Network & Distribution Centers, DePuy Synthes Quality & Regulatory organizations, , FDA, ISO and State Regulatory Agencies as required.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via . internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:

Preferred Skills:
The anticipated base pay range for this position is :
$94,000.00 - $151,800.00Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

Holiday pay, including Floating Holidays –13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - Originally posted on Himalayas