Assoc. Dir, QRM Lead

Job Description

The Quality Risk Management (QRM) Lead role will involve establishing the QRM structure at our companys Wilmington Biotech site ensuring the processes conform to our companys policies and comply with cGMPs Health Agency regulations and all other applicable governing regulations with the mission and ambition to manufacture breakthrough medicines for patients around the world.

Close collaboration with high performance talent from our companys global team and the biotechnology industry to develop and execute multiple Quality Assurance systems and processes will be key and the successful candidate will inspire the site to take a quality risk management mindset to build the future of our companys antibody drug conjugates and high potent compounds through a QRM program that delivers unconstrained supply that is Right First Time to patients worldwide.

Throughout the development of the new facility the successful candidate will focus on commissioning qualification and/or validation of the facility equipment and process. The candidate will also establish the Risk Governance Council for the site ensuring risks are reviewed and mitigated across the lifetime of the site.

POSITION RESPONSIBILITIES

With energy and enthusiasm the Quality Risk Management Lead will:

1. In-depth knowledge of US and European GMP guidelines

2. ICH and other international regulatory requirements as applicable to the site.

3. Drive compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements.

4. Be an advocate of continuous improvement through QRM.

5. Responsible to develop and maintain Quality Risk Management (QRM) Expertise.

6. Responsible for supporting QRM site deployment

7. Responsible for activities involved in the implementation of a harmonized QRM program including standards business processes tools and training for the site

8. Responsible for facilitation of Quality Risk Assessments

9. Responsible for partnering with customers across site key stakeholders and management to communicate/escalate and ensure timely and adequate management of quality risks

10. Responsible for maintenance of Site Quality Risk tracking documentation.

11. Responsible for identifying and implementing continuous improvement initiatives within the site QRM business processes in alignment with the QRM CoE program including integration into the quality management system

12. Accountable for review of site level QRM activities

13. Accountable for on-time schedule-based risk reviews.

14. Accountable for ensuring that all those involved in QRM activities meet QRM training requirements.

15. Support regulatory inspections and audits as requested.

16. Collaborates with QRM Community of Practice members across the division.

17. Participates on or leads teams supporting internal functions and/or evaluating site processes for improvement opportunities.

18. Responsible for identifying and implementing continuous improvement initiatives within the site QRM business processes in alignment with the QRM CoE program including integration into the quality management system.

19. Accountable for ensuring that all those involved in QRM activities meet QRM training requirements

REPORTING STRUCTURE

This position will report into the Site Quality Lead

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

General

This role requires a seasoned Associate Director with a minimum of 10 years experience in Quality Control Quality Assurance or Pharmaceutical Vaccine or Biological Operations or Technical Operations.

A self-starter and results-focussed the successful candidate will have strong contemporary knowledge of relevant cGMPs regulations and current industry trends.

Technical

• Demonstrated knowledge of Quality Management System tools continuous improvement methodologies & in-depth understanding of site level products & related processes.

• Demonstrated understanding of continuous quality / process improvement tools (As defined by the site e.g. DMAIC Lean QA 5S etc).

• Exceptional analytical problem solving & root-cause analysis skills.

• Ability to multi-task and handle tasks with competing priorities effectively.

• Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures) global regulatory experience & demonstrated experience interfacing with regulators.

• Strong operations support background ensuring value added and effective quality oversight

People

• Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA) complaints & risk management; & product quality improvement using tools such as six sigma DFR etc.

• Excellent communication skills (written and oral).

• Required to work on his/her own initiative in addition to working as part of a team. Must be able to work across a team matrix in order to meet accelerated timelines.

• Desire to continuously learn improve and develop.

• Ability to facilitate groups with diverse perspectives and influence and bring teams to consensus and alignment.

• Effective communication presentation and interpersonal skills to interface effectively with all levels of colleagues and with external customers in a team orientated manner.

• Able to demonstrate good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions; communicates influences and escalates issues and decisions as needed.

• Planning and scheduling skills Proven organizational skills Flexible approach.

• Goal/results orientated Starter/Finisher.

Education Requirement:

• B.S M.S or PHD in Chemistry Biology Microbiology Automation Engineering or equivalent.

Required Experience and Skills:

• Minimum of 10 years experience in Quality Control Quality Assurance or Pharmaceutical Vaccine or Biological Operations or Technical Operations.
• Experience in Quality Risk Management
• Global regulatory experience & demonstrated experience interfacing with regulators
• Strong contemporary knowledge of relevant cGMPs regulations and current industry trends.
• Experience in Quality Management Systems
• In-depth knowledge of global health authority regulations and quality compliance requirements
• Strong management and leadership experience.
• Ability to facilitate groups with diverse perspectives and influence and bring teams to consensus and alignment.
• Strong verbal and written communication skills project management skills.

Preferred Experience and Skills:

• Direct experience in manufacture of antibody drug conjugates.
• DMAIC Lean QA 5S Experience

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U.S. Hybrid Work Model

Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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