Sr. Manager Quality Compliance - Integra LifeSciences
Plainsboro, NJ
About the Job
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
This Senior Manager, Quality Operations will manage and provide oversight on Quality Compliance for change control projects and daily operations which may include leading project teams focused on key initiatives including quality process improvements, process changes, and other site quality support projects. Responsible for assessing, developing and maintaining compliance for plant quality audit, site GAP Analysis coordination, QA Release, Document control, training requirements, and data analysis activities (i.e. QMR, Metrics). Oversee generation and review of documents, processes. This position will also focus on key initiatives in addition to base business priorities related to Compliance. They will perform all duties in accordance to the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies.
SUPERVISION RECEIVED
Receives minimal supervision from the Director, CMC Quality Operations.
SUPERVISION EXERCISED
Manages personnel supporting quality compliance areas including Change Control/Document Control, Training, QA Release, Data analysis, and Internal Auditing. May include Supervisors, Auditors, Compliance Specialists, Training Specialists, Change Coordinators, etc.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
+ Responsible for ensuring site processes maintain compliance with Global and Regional policies and procedures, US and Global QSRs
+ Ensure cross-functional partners understand quality system requirements and how they impact product quality and regulatory compliance.
+ Works with Senior Management to achieve alignment of Quality Goals and functions and ensure proper resourcing.
+ Identifies the minimum baseline training requirements for all personnel at the plant.
+ Ensures document control program is effective and efficient.
+ Ensures Internal Auditing maintains compliance to identify site items requiring remediation.
+ Ensures QA Release functions are maintained compliantly and in coordination with Supply Chain goals as applicable.
+ Maintain data analysis requirements associated with Monthly Metrics and QMRs.
+ Engage in team development.
+ Participates in FDA inspections, ISO certifications, surveillance audits, and customer audits.
+ Identify and implement opportunities for continuous improvement, including document revisions in order to maintain accurate SOPs.
+ Provide compliance support to various departments as needed, e.g. engineering, product development, etc.)
+ Ensure metrics are prepared and compiled for Quality Management Reviews.
+ Assist in training new associates according to the Quality System Regulations and company SOPs as applicable.
+ May also perform other related duties, responsibilities, and special projects as assigned.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
+ B.S. degree in life science or engineering and minimum 8 years in progressive experience in Medical Device or Pharma.
+ At least 4 years medical device or pharma managerial experience directly managing people or leadership experience leading project teams and/or programs.
+ Extensive knowledge of appropriate global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, 820, ISO 13485, ISO 14971 and Medical Device Directive, EUMDR.
+ Demonstrated ability to build an engaged and cohesive team, maintain a positive working environment and integrate quality objectives across multiple functions
+ Excellent written and verbal communication skills. Must be able to effectively present at staff and department meetings.
+ Strong organizational skills, self-directed, strong problem solving and interpersonal skills.
+ Must be able to work independently with minimal supervision required.
+ Expert MS office user a plus.
+ ASQ-CQT desirable.
+ Ability to define problems, collect data, establish facts and draw valid conclusions
+ Ability to work effectively in a cross functional environment
+ Attention to detail, strong time management are essential
TOOLS AND EQUIPMENT USED
Computer skills to include MS Word, MS Excel, MS outlook, Ability to utilize a computer, telephone, copier, fax as well as other general office equipment proficiently. Able to train on measurement equipment use.
PHYSICAL REQUIREMENTS
The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
While undertaking the essential duties and responsibilities of the position, the employee must repeatedly
sit, listen, speak, and write in English. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 25lbs.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
This Senior Manager, Quality Operations will manage and provide oversight on Quality Compliance for change control projects and daily operations which may include leading project teams focused on key initiatives including quality process improvements, process changes, and other site quality support projects. Responsible for assessing, developing and maintaining compliance for plant quality audit, site GAP Analysis coordination, QA Release, Document control, training requirements, and data analysis activities (i.e. QMR, Metrics). Oversee generation and review of documents, processes. This position will also focus on key initiatives in addition to base business priorities related to Compliance. They will perform all duties in accordance to the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies.
SUPERVISION RECEIVED
Receives minimal supervision from the Director, CMC Quality Operations.
SUPERVISION EXERCISED
Manages personnel supporting quality compliance areas including Change Control/Document Control, Training, QA Release, Data analysis, and Internal Auditing. May include Supervisors, Auditors, Compliance Specialists, Training Specialists, Change Coordinators, etc.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
+ Responsible for ensuring site processes maintain compliance with Global and Regional policies and procedures, US and Global QSRs
+ Ensure cross-functional partners understand quality system requirements and how they impact product quality and regulatory compliance.
+ Works with Senior Management to achieve alignment of Quality Goals and functions and ensure proper resourcing.
+ Identifies the minimum baseline training requirements for all personnel at the plant.
+ Ensures document control program is effective and efficient.
+ Ensures Internal Auditing maintains compliance to identify site items requiring remediation.
+ Ensures QA Release functions are maintained compliantly and in coordination with Supply Chain goals as applicable.
+ Maintain data analysis requirements associated with Monthly Metrics and QMRs.
+ Engage in team development.
+ Participates in FDA inspections, ISO certifications, surveillance audits, and customer audits.
+ Identify and implement opportunities for continuous improvement, including document revisions in order to maintain accurate SOPs.
+ Provide compliance support to various departments as needed, e.g. engineering, product development, etc.)
+ Ensure metrics are prepared and compiled for Quality Management Reviews.
+ Assist in training new associates according to the Quality System Regulations and company SOPs as applicable.
+ May also perform other related duties, responsibilities, and special projects as assigned.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
+ B.S. degree in life science or engineering and minimum 8 years in progressive experience in Medical Device or Pharma.
+ At least 4 years medical device or pharma managerial experience directly managing people or leadership experience leading project teams and/or programs.
+ Extensive knowledge of appropriate global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, 820, ISO 13485, ISO 14971 and Medical Device Directive, EUMDR.
+ Demonstrated ability to build an engaged and cohesive team, maintain a positive working environment and integrate quality objectives across multiple functions
+ Excellent written and verbal communication skills. Must be able to effectively present at staff and department meetings.
+ Strong organizational skills, self-directed, strong problem solving and interpersonal skills.
+ Must be able to work independently with minimal supervision required.
+ Expert MS office user a plus.
+ ASQ-CQT desirable.
+ Ability to define problems, collect data, establish facts and draw valid conclusions
+ Ability to work effectively in a cross functional environment
+ Attention to detail, strong time management are essential
TOOLS AND EQUIPMENT USED
Computer skills to include MS Word, MS Excel, MS outlook, Ability to utilize a computer, telephone, copier, fax as well as other general office equipment proficiently. Able to train on measurement equipment use.
PHYSICAL REQUIREMENTS
The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
While undertaking the essential duties and responsibilities of the position, the employee must repeatedly
sit, listen, speak, and write in English. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 25lbs.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
Source : Integra LifeSciences