QA Manager, Quality Risk Management

Astellas Pharma • Sanford, NC

115d

About The Position

The QA Manager, Quality Risk Management (QRM) will be responsible for the execution and management of the QRM program elements, including but not limited to, creation of procedures, work instructions, forms/templates, etc., leading/facilitating QRM assessments, collaborating with key stakeholders to ensure all elements of QRM are carried out through established work practices, and ensuring consistent application of QRM system compliance with Astellas local/global procedures and policies, and applicable regulatory requirements. Executes process/continuous improvement and supports new technology initiatives for Astellas. Contributes to and leads in the development, implementation, and successful execution of the QA mission, objectives and 3-5-year strategic plan. This role is pivotal in driving ongoing improvements in operational efficiency, ensuring that the organization meets its strategic objectives.

Requirements

• Bachelor's degree in a scientific or technical discipline, and 10+ years of pharmaceutical experience in biotechnology or pharmaceutical industry in quality or quality risk management systems, 8+ years of experience with MS and 6+ years of experience with PhD, or equivalent combination of education and experience.
• 4+ years related management experience (people/processes or systems), including consistently creating opportunities for colleagues to improve their knowledge and skills needed in their current job; showing courage in delivering feedback focused on improving colleague performance.
• Experience building, executing, integrating, leading, and maintaining QRM systems.
• Proven QA experience including successful implementation and oversight of Quality Management Systems, inspection readiness and health authority inspection management in a cGMP biologics manufacturing environment.
• Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Interacts with senior management or executive levels on matters concerning several functional areas.
• Strong analytical, communication, and negotiation skills as well as sound judgment, with the ability to work effectively with others.
• Expert level knowledge of US and International GMPs, FDA/ICH Guidance, and best practices in a biotech manufacturing and testing environment.
• Proven ability and enthusiasm to lead, motivate, inspire, develop, and encourage colleagues.
• Well-organized and detailed oriented professional, with strong verbal and written communication skills.
• Advanced computer skills with working knowledge of MS office such as Word, Excel, and Adobe Acrobat.
• Must be self-motivated with ability to handle, organize and prioritize multiple tasks and be able to perform under pressure to meet production deadlines.

Nice To Haves

• Experience in a GMP facility startup, high growth, and fast-paced environment.
• Experience working with Quality systems in a commercial-ready gene therapy facility.
• Ability to proactively predict and resolve complex problems, think strategically and tactically, and to execute/implement solutions to complex problems.

Responsibilities

• Execute daily program level responsibilities, including development and implementation of QRM processes and continuous improvements to ensure productivity and alignment with departmental/site/global goals.
• Drive a culture of continuous quality improvement across the organization, leading initiatives that enhance service delivery and patient care.
• Establish and foster a cGMP quality culture that prepares the site for regulatory pre-approval inspections and eventual licensure for commercial manufacturing.
• Manage multiple assigned projects concurrently.
• Build relationships and initiate collaboration with key counterparts, functional area leaders, and stakeholders across campuses to establish and identify process improvement initiatives and to identify, assess, and prioritize risks across all operations, implementing strategies to mitigate these risks effectively.
• Provide support to Manufacturing, Facilities, Supply Chain, and other supporting function stakeholders to ensure QRM processes are utilized as required.
• Prepare and provide comprehensive reports on quality and risk management activities, utilizing performance metrics to identify areas for improvement.
• Assist in the implementation of global systems for the QRM program, including implementation and release of future changes.
• Provide collaboration and guidance for the development and continuous improvement of QRM training to ensure QRM compliance, as well as specialized QRM facilitator training across all GxP functions.
• Provide guidance and support to other BioPharma Quality sites during implementation of QRM program principles to ensure consistent implementation.
• Leads risk assessments to identify and address key quality issues, ensuring risks are escalated and managed appropriately within BioPharma QA.
• Monitors compliance with Health Authority regulations and guidance throughout the product lifecycle, supporting ongoing quality and compliance initiatives in BioPharma.
• Participate and represent the company in regulatory (e.g., FDA, EMA, DHHS, etc.) inspections and audit activities conducted by third-party and corporate partners as process owner for QRM.
• Performs other duties as assigned.

Benefits

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Referral bonus program

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Management of Companies and Enterprises
• Education Level: Bachelor's degree