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Project Manager, Supply Quality Compliance-3113131127
Description
Animas Corporation, a member of the Johnson & Johnson Family of Companies, is recruiting for a Project Manager, Supply Quality Compliance that will be located in the West Chester, PA.
Animas Corporation develops and manufactures insulin delivery systems that help people living with diabetes better manage the disease and live a life without multiple daily insulin injections. Animas is dedicated to helping make diabetes management easier through exceptional customer support, educational programs and innovative products. Animas employees are dedicated in “creating a world without limits for diabetics,” so it's no surprise that the company has led the way in insulin pump innovations since its first pump launched in 2000. To learn more visit www.animas.com.
The role of the SQC Project Manager will ensure an effective supplier quality audit program and an effective FDA Readiness program for key critical suppliers. The individual will be accountable for the absence of significant quality issues and regulatory compliance actions by government agencies. The SQC Project Manager will be accountable for the proactive identification and alerting of quality issues in time to resolve, along with ensuring effective regulatory agency inspections.
The SQC Project Manager will develop and execute organizational and operational policies for the franchise wide quality system supplier quality audit program. The individual will manage external auditors/contract auditors and make decisions regarding work processes or operational plans and schedules in order to achieve department objectives. He/she will assess proposed regulations and communicate new requirements to the organization. The SQC Project Manager will alert the organization to existing and potential problems and risks, as well as provide compliance and quality consultation services. The individual will collaborate with functional department to establish effective CAPAs and conduct supplier audits and gap assessments in support of the supplier quality audit program and FDA Readiness. He/she will monitor supplier quality audit program performance through the use of trending and metrics. The position will serve as a consultant, making recommendations and corrective actions, which are required regarding audit results, and compliance to written procedures or applicable government. The individual with maintain files containing audit reports, re-audit reports, and audit responses, and pertinent corrective action follow-up for audits conducted in support of the supplier quality audit program. The SQC Project Manager will review audit responses and assist with required training in response to audit findings and other GMP/ISO/JPAL related issues as needed. He/she will provide advice and guidance to less seasoned Quality System Auditors. The role will also maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and stand for long periods of time. Specific vision abilities required by this job include close vision. While performing the duties of this job, the employee occasionally works near moving mechanical parts and is occasionally exposed to fumes or airborne particles and risk of electrical shock.
Qualifications
A minimum of a BS in a scientific or technical field is required. A minimum of 5 years experience in quality compliance with recent experience in the medical device and diagnostics industry is required. Certified quality auditor and/or lead auditor is preferred. Experience with quality systems and compliance is required. Supplier related experience is preferred. A strong leadership ability, interpersonal, communication and influencing skills required. Demonstrated compliance experience in domestic and international medical device and combination product quality systems is preferred. Knowledge of FDA CFR Part 820, Part 11 and ISO 130485 regulations is required. The ability to select, manage and direct a team during an audit is preferred. Strong statistical skills and manufacturing process understanding is preferred.
The ability to analyze, balance and prioritize risk is important for this role. Ability to read, analyze and interpret scientific and technical journals, financial reports and legal documents. Ability to respond to common inquiries, regulatory agencies, or members of the business community. Ability to lead a team through a root cause analysis problem. Ability to present information to top management, public groups and/or boards of directors. Engages in constructive conflict. High tolerance for ambiguity in a complex environment. Makes the complex clear and easily understood by others.
This position is located in West Chester, PA and may require up to 30-40% domestic and international travel.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-Pennsylvania-West Chester
Organization: Animas Corporation (6150)
Job Function: Quality (Generalist)
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Project Manager, Supply Quality Compliance-3113131127
Description
Animas Corporation, a member of the Johnson & Johnson Family of Companies, is recruiting for a Project Manager, Supply Quality Compliance that will be located in the West Chester, PA.
Animas Corporation develops and manufactures insulin delivery systems that help people living with diabetes better manage the disease and live a life without multiple daily insulin injections. Animas is dedicated to helping make diabetes management easier through exceptional customer support, educational programs and innovative products. Animas employees are dedicated in “creating a world without limits for diabetics,” so it's no surprise that the company has led the way in insulin pump innovations since its first pump launched in 2000. To learn more visit www.animas.com.
The role of the SQC Project Manager will ensure an effective supplier quality audit program and an effective FDA Readiness program for key critical suppliers. The individual will be accountable for the absence of significant quality issues and regulatory compliance actions by government agencies. The SQC Project Manager will be accountable for the proactive identification and alerting of quality issues in time to resolve, along with ensuring effective regulatory agency inspections.
The SQC Project Manager will develop and execute organizational and operational policies for the franchise wide quality system supplier quality audit program. The individual will manage external auditors/contract auditors and make decisions regarding work processes or operational plans and schedules in order to achieve department objectives. He/she will assess proposed regulations and communicate new requirements to the organization. The SQC Project Manager will alert the organization to existing and potential problems and risks, as well as provide compliance and quality consultation services. The individual will collaborate with functional department to establish effective CAPAs and conduct supplier audits and gap assessments in support of the supplier quality audit program and FDA Readiness. He/she will monitor supplier quality audit program performance through the use of trending and metrics. The position will serve as a consultant, making recommendations and corrective actions, which are required regarding audit results, and compliance to written procedures or applicable government. The individual with maintain files containing audit reports, re-audit reports, and audit responses, and pertinent corrective action follow-up for audits conducted in support of the supplier quality audit program. The SQC Project Manager will review audit responses and assist with required training in response to audit findings and other GMP/ISO/JPAL related issues as needed. He/she will provide advice and guidance to less seasoned Quality System Auditors. The role will also maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and stand for long periods of time. Specific vision abilities required by this job include close vision. While performing the duties of this job, the employee occasionally works near moving mechanical parts and is occasionally exposed to fumes or airborne particles and risk of electrical shock.
Qualifications
A minimum of a BS in a scientific or technical field is required. A minimum of 5 years experience in quality compliance with recent experience in the medical device and diagnostics industry is required. Certified quality auditor and/or lead auditor is preferred. Experience with quality systems and compliance is required. Supplier related experience is preferred. A strong leadership ability, interpersonal, communication and influencing skills required. Demonstrated compliance experience in domestic and international medical device and combination product quality systems is preferred. Knowledge of FDA CFR Part 820, Part 11 and ISO 130485 regulations is required. The ability to select, manage and direct a team during an audit is preferred. Strong statistical skills and manufacturing process understanding is preferred.
The ability to analyze, balance and prioritize risk is important for this role. Ability to read, analyze and interpret scientific and technical journals, financial reports and legal documents. Ability to respond to common inquiries, regulatory agencies, or members of the business community. Ability to lead a team through a root cause analysis problem. Ability to present information to top management, public groups and/or boards of directors. Engages in constructive conflict. High tolerance for ambiguity in a complex environment. Makes the complex clear and easily understood by others.
This position is located in West Chester, PA and may require up to 30-40% domestic and international travel.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-Pennsylvania-West Chester
Organization: Animas Corporation (6150)
Job Function: Quality (Generalist)
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.