Sr. Director, QC Analytical Methods

Position Overview:

The Sr. Director, Quality Control, Analytical Methods will provide strategic leadership to Quality Control teams based in Durham, North Carolina, and Cambridge, Massachusetts. This role is accountable for the full lifecycle management of analytical methods, including technical transfer, qualification, validation, and remediation, both internally and externally. The incumbent will oversee routine GMP in-process, release, and stability testing, and play a pivotal role in shaping and executing the long-term quality control testing strategy for clinical and commercial programs. This position reports directly to Beam’s Vice President of Quality Control.

Responsibilities:

• Deliver comprehensive Quality Control leadership across multiple programs and cross-functional forums.
• Develop and implement robust QC strategies for method qualification, transfer, and validation in collaboration with Analytical Development and other key stakeholders (e.g., Product Quality Leads).
• Provide strategic direction to Quality Control teams in North Carolina and Massachusetts, ensuring excellence in method lifecycle management and product quality testing and stability.
• Serve as a QC leader in interactions with Beam’s suppliers (e.g., CMOs/CTLs) and the internal manufacturing site in Durham, North Carolina.
• Establish and monitor metrics for all testing aspects, including in-process, release, stability testing, and OOT/OOS results.
• Partner with Quality Assurance to ensure contract laboratory service providers are appropriately qualified and that Quality Agreements are comprehensive, approved, and regularly updated.
• Ensure strict adherence to GMP principles within internal and external laboratories.
• Maintain compliance of quality control systems and equipment with all applicable regulatory guidelines, upholding data integrity to ensure confidence in generated data.
• Track and analyze GMP data, including the evaluation and approval of data from external contract laboratories.
• Compile and present data with insightful interpretations for management reviews, Annual Product Reviews, and other required assessments.
• Drive continuous improvement initiatives across the Quality Control Group.

Qualifications:

• Bachelor’s or advanced degree in scientific discipline.
• Minimum of 18 years’ experience in the pharmaceutical/biotech industry, encompassing drug substance/drug product manufacturing, development, and/or quality. Direct experience with cell and/or gene therapy programs is strongly preferred.
• Experience with implementing, validating, and overseeing execution of automated test methods.
• Proven experience leading teams in Quality and Quality Control functions.
• Demonstrated support for all phases of a program’s lifecycle (pre-IND through commercial lifecycle management).
• At least 10 years of Quality management experience.
• Exceptional verbal and written communication skills, with a detail-oriented approach and the ability to drive change across functions.
• Experience engaging with regulatory health authorities during pre- and post-approval inspections.
• In-depth knowledge of global regulations and standards.
• Collaborative team player with a customer service mindset and solution-oriented approach.
• Strong attention to detail and ability to work independently, within multidisciplinary teams, and with external partners and vendors.
• Outstanding team building, leadership, and management skills.
• Excellent listening, communication, and interpersonal skills that foster team spirit.
• Consistent delivery of high-quality work.
• Superior skills in managing vendors and stakeholders involved in Quality and Regulatory activities to achieve corporate objectives.
• Strong team player that has a customer service approach and is solution oriented.
• Must be able to work onsite daily and willing to have a flexible schedule during peak times, which may include supporting critical operations outside of normal work hours, as needed.

Relocation assistance is available for qualified candidates.