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Sr Director Quality Systems

Regeneron

Regeneron

Quality Assurance
Limerick, Ireland
Posted 6+ months ago

The Sr Director Quality Systems will be responsible for leading all aspects of the quality systems program initiatives for all of Regeneron. Responsibilities will include being responsible for executing global and site initiatives ensuring that robust quality systems are defined, and operational, proficient system owners are identified, adequately trained and understand expectations and deliverables. The Sr Director Quality Systems will have direct responsibilities for interfacing with global quality system personnel ensuring the site efforts are aligned and delivering on expected results. They will lead the development and maintenance of the overall systems quality plan. They will interact directly with all sites and global staff and with management in areas representing the quality systems and quality plan, including presenting program efforts, coordination and owning metrics, determining target goals and presenting periodic reviews of Systems and Quality plan preparation and performance. This individual will have direct authority and accountability to ensure Quality Systems exist and System owners are provided tools and support needed to deliver on written expectations.

A typical day might include, but is not limited to, the following:

  • Leading all aspects of the establishment of Quality Systems appropriate to the IOPS operations

  • Leading the identification of Quality System owners and providing them the leadership and tools to define their roles & responsibilities, detailed workflows and establishment of meaningful metrics

  • Managing the Right to Operate Review meetings where quality system or Quality Plan project metrics are presented. Ensuring Quality System owners meet management review metric expectations and can represent data appropriately

  • Developing the structure and expectations for Quality System owners to execute upon.

  • Interacting with senior management, system owners, and global program stakeholders to represent the Quality Plan and Quality System owners program initiatives and expectations

  • Representing the Quality Management System to represent initiatives and program meetings

  • Coaching and mentoring staff and being the primary interface with Information Systems in support of the Quality Plan and Quality Systems programs

This role might be for you if you:

  • Have the ability to build a vision of the capabilities and then lead a group to that state.

  • Have comprehensive knowledge of Quality Systems expectations throughout drug development process, pharmaceutical technology, drug manufacturing processes and related issues, drug laws, global regulations, and guidelines, particularly CMC and GMP

  • Have experience building up a Quality culture and Quality management capabilities.

  • Have comprehensive knowledge and experience with regulatory filings and inspections.

  • A sense of passion and commitment for delivering things as quickly and efficiently as possible

  • Possess the ability to think and operate in a rapidly evolving and ambiguous environment

  • Are able to articulate and execute concepts for developing and ensuring the highest quality throughout the network (internal and external)

  • Have an intellect for Quality Risk identification, mitigation, and management

  • Have demonstrated experience accomplishing goals and delivering results through the management of subordinates

  • Are a change agent capable of recognizing mediocrity, defining required changes, and delivering decisively

  • Have strong communication skills —written and oral

  • Have experience with businesses in different phases of the business lifecycle and the quality and validation issues associated with these phases

To be considered for this position you must hold a bachelor’s or master’s degree in life sciences or program management. A minimum of 15 years of experience leading QA/QC programs and personnel in the pharmaceutical or biopharmaceutical regulated industry. General knowledge of quality assurance, systems, processes and regulations relate to the manufacture of biopharmaceutical products. Excellent interpersonal relationship skills, the ability to operate and deliver results in a matrix managed environment, and work independently and comfortable with making program level decisions based on collaborative input. Must have exceptional communication skills.

#LI-Onsite #JOBSIEPR #REGNIEQA #IREADV

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.