Immucor Disability Jobs

Contact us directly at careers@immucor.com

immucor logo
TransfuseTransplantTransforma life
immucor logo mobile

Job Information

Immucor, Inc. Director, Quality & Regulatory Affairs in Warren, New Jersey

Overview

Founded in 1982 and based in Norcross, GA, Immucor is a global leader in transfusion and transplantation diagnostics products that facilitate patient / donor compatibility worldwide. Our mission is to ensure that patients in need of blood, organs, or stem cells get the right match that is safe, accessible, and affordable. The result is life changing for patients in need of a transfusion or transplant. Our new corporate identity illustrates the right match of donors with patients in need of blood or a specific organ, as well as Immucor’s partnership with healthcare organizations in need of innovation and productivity. With the right match, we can transform a life together!

We are seeking a driven and results-oriented leader to join our Quality team. In this role, you will be responsible for the site Quality system and leadership of the site Quality Assurance, Quality Control and Regulatory Affairs organization. Ensures that a site Quality Management System is established, implemented and maintained for product manufacturing, control, storage, and primary distribution processes in accordance with applicable US Federal Regulations, Regulation EU 2017/746, EN ISO 13485 standards and Immucor's Quality requirements. Member of the site leadership team and, in partnership with the site operations leader, will sponsor a Quality and Compliance-focused culture which embraces Right First Time and Continuous Improvement expectations. If you are interested in joining an organization where your talents and expertise will be highly appreciated, and if you meet our qualifications to excel in this position, we want to hear from you.

This position is not eligible for sponsorship for work authorization by Immucor, Inc. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time .

Director, Quality & Regulatory Affairs

Responsibilities

As Director, Quality & Regulatory Affairs, you will direct all GMP aspects of plant activities. Interfaces with other top management personnel to set policy and to assure adherence to these, in addition to governmental standards. Responsible for the decision on acceptability and release of all site products. Organizational responsibilities include site Quality Assurance, Quality Control and Regulatory Affairs documentation, and regulatory inspection / customer audit liaison activities. Additional responsibilities include site department budget, hiring and development of personnel, and management of the Quality and RA organization.

Other responsibilities of the Director, Quality & Regulatory Affairs role include:

  • Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance.

  • Implements policies and procedures to ensure that these are in compliance with the appropriate statutes and regulations and ensures that regulatory reporting requirements are met.

  • Ensure quality system performance is measured and routinely reported to the executive management.

  • Ensure regulatory filing strategies and market authorizations are developed and supported through product development and lifecycle management

  • Liason and support EU Authorized Representative to ensure compliance to EU regulatin, regulatory correspondence, and maintenance of technical documentation.

  • Ensure regulatory filing strategies and market authorizations are developed and supported through product development and lifecycle management

  • Responsible for the overall surveillance and operation success of assigned functions and for successfully integrating these activities with those of other major organizational segments

  • Serves as the site Management Representative and Person Responsible for Regulatory Compliance (PRRC), as defined by 21CFR part 820 the In Vitro Diagnostic Regulation (IVDR) Regulation (EU) 2017/746

  • Directs the risk management and design control strategy for the development and manufacture of new and existing Medical Device products.

  • Acts independently, guided only by very broad company policies and objectives. Makes final decisions on administrative or operational issues affecting major segments or functional activities of the organization

  • Actions as site quality and regulatory contact to support design activities performed at the Mt. View (CA) site.Directs and controls the activities of one or more functional areas, divisions, product groups, service groups, etc. through senior managers and/or directors with overall responsibility for the direction of those assigned areas.

  • Determines actual organizational structures and allocation of subordinate management responsibilities.

  • Assist the Management Representative in escorting and providing information to regulatory officials during company audits/inspections.

  • Performs a variety of managerial tasks and duties to ensure the appropriate day to day operations of Quality Assurance, Quality Control, and Regulatory Affairs.

  • Ensures activities are completed within scheduled timeframes. (i.e. regulatory submissions/reports, CAPAs, investigations, MDRs/Vigilance/FSCA/ complaint closure, etc.)

  • Ensures adequate training (and documentation) of employees within the departments listed above

  • Participates in the design and implementation of new products and processes.

  • Prepare, maintain and ensure adherence to departmental budgets.

  • Manage personnel attendance and perform employee appraisals and competency evaluations.

Director, Quality & Regulatory Affairs

Qualifications

As Quality Director, you will perform a variety of managerial tasks and duties to ensure the appropriate day to day operations of Manufacturing Quality Assurance, Document Control and Quality Investigation/CAPA functions. This position ensures activities are completed within scheduled timeframes (i.e. CAPAs, investigations, etc.). You will also ensure adequate training (and documentation) of employees within the departments listed above.

Other requirements of the Director of Quality role include:

  • BS degree or equivalent in Science or Engineering.

  • Minimum 10 years experience in Quality Assurance /Regulatory Affairs

  • Minimum of 10 years experience in the medical device industry, and/or biopharma industry.

  • Minimum of 5 years in a management or supervisory position within a medical device company or equivalent.

  • Demonstrated track record in successful US FDA, EU and ROW premarket submissions and registrations and recent / pending regulatory changes

  • Previous experience in an in-vitro diagnostics quality assurance/regulatory affairs leadership role preferred

  • Demonstrated knowledge and understating of 510k requirements, and IVDD/IVDR regulations

  • Demonstrated knowledge and understanding of the Quality System Regulations (QSR), 21CFR Parts 210,211, 11, and 820, ISO 14385, ISO 14971 requirements and other related regulations with emphasis in CAPA Systems.

Director, Quality & Regulatory Affairs

IMMUCOR, INC IS AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER; MINORITY/FEMALE/DISABILITY/VETS; DRUG FREE WORKPLACE

RESUMES SUBMITTED TO IMMUCOR FROM THIRD PARTY RECRUITMENT FIRMS WILL NOT BE CONSIDERED.

This position is not eligible for sponsorship for work authorization by Immucor, Inc. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time.

Immucor offers a comprehensive benefits package available on the start date of your employment, including:

  • Medical, prescription, dental, and vision insurance – we offer multiple plan options so you can determine which best suits your needs and the needs of your dependents

  • Wellness program

  • STD/LTD/Life insurance all 100% company paid

  • Voluntary life/accident/hospital indemnity insurance for yourself, spouse/domestic partner and dependents

  • Tuition reimbursement

  • Company matched 401k plan

  • Vacation/Company & Personal Holidays/Sick days

Where permitted by applicable law, must have received at least the first COVID-19 vaccine by the date of hire and receive the final vaccination within the manufacturers recommended guidelines, or have an approved Immucor exemption by December 8, 2021, to be considered for U.S.-based job. If not currently employed by Immucor, Inc. Proof of vaccination status will be required on first day of employment.

Job Locations US-NJ-Warren

Job ID 2021-2789

Category Quality


Careers | Privacy Statement | Quality Policy | Legal | Site Map

EOE including Disability/Protected Veterans

If you are unable to apply using our online application system, due to a disability, please contact +1.678.421.1269 or +1.678.421.1294. Please indicate the specific assistance needed. This option is reserved for people with disabilities only.

DirectEmployers