Sebela Pharmaceuticals is a U.S. pharmaceutical company with a market-leading position in Gastroenterology and a focus on innovation in Women's Health. Our Vision is to build the leading Gastroenterology company in the U.S., with a complementary

focus on innovation in Women's Health, premised on our expertise in pharmaceutical development and commercialization. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, has its contract development and manufacturing organization (CDMO) in Holbrook, MA, offering pharmaceutical-development and in-house manufacturing services for specialty gastroenterology products.

We value dedication, energy, and enthusiasm, and we focus on innovation and results while striving to achieve our corporate mission and vision. Sebela Pharmaceuticals is committed to cultivating an inclusive environment where all employees are treated with respect. We accomplish this by fostering a culture of diversity, equity and inclusion, which is essential to innovation and continuous improvement. Sebela operates from three locations in Roswell, Georgia, Braintree and Holbrook, MA and headquarters in Dublin, Ireland.

This position is responsible for leading Quality Controls Laboratory operations at the Holbrook site including the development, implementation and maintenance of quality control systems and activities to support commercial manufacturing and new product introductions.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Provide strategic leadership and oversight of QC operations, ensuring alignment with company objectives for product quality, regulatory compliance, and business performance.
• Direct all QC laboratory activities, in support of GMP Testing, release, and stability programs, including laboratory safety, testing operations, resource allocation, and performance management.
• Review and approve QC specifications, procedures, protocols, validation documents, and analytical methods related to raw materials, intermediates, and commercial products.
• Ensure all testing is performed in accordance with internal procedures and cGMP requirements.
• Lead investigations into Out-of-Specification (OOS) results and laboratory deviations ensuring timely root cause identification and implementation of effective corrective and preventive actions (CAPAs).
• Maintain inspection readiness across QC operations, supporting regulatory inspections, customer audits, and internal quality audits.
• Oversee laboratory change control processes, risk assessments, equipment qualification activities, and implementation of compliant operational improvements.
• Ensure critical laboratory equipment is appropriately qualified, calibrated, maintained, and operated to support reliable testing and maintain data integrity.
• Ensure laboratory data integrity, documentation accuracy, and adherence to ALCOA principles
• Partner with Quality Assurance, Manufacturing, and external stakeholders to investigate product quality issues and drive continuous improvement initiatives.
• Lead supplier quality support activities, including supplier qualification, performance monitoring, and resolution of supplier-related quality issues.
• Monitor and analyze QC performance metrics and quality system trends to identify risks, drive operational excellence, and strengthen compliance.
• Develop, mentor, and retain a high-performing QC organization, fostering a culture of accountability, collaboration, and continuous professional development.
• Manage departmental budgets, capital planning, and resource requirements to ensure effective execution of business and quality objectives.
• Other duties as assigned.

KEY COMPETENCIES:

• Leadership and teamwork
• Regulatory Compliance, cGMP, Statistical Process Control
• Extensive analytical chemistry experience
• Project management
• Data collection, management and analysis
• Ability to direct and be resilient and focused under pressure
• Planning and time management
• Strong decision-making skills
• Ability to manage multiple priorities
• Ability to foster excellent working relationships across all levels, internal/external customers and suppliers

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential function satisfactorily, be flexible in terms of work hours, and have strong knowledge and experience in cGMPs and Oral Dose Pharmaceutical Production Processes. The requirements listed below are representative of the knowledge, skills and/or abilities required.

• BS or master's degree in chemistry, biology, or other pharmaceutical science related field.
• Minimum of 8-10 years QC management experience working in pharmaceutical finished product manufacturing with experience in compliance, quality control, and regulatory development.
• Direct experience interacting with FDA and other regulatory agencies.
• Strong knowledge and understanding of FDA cGMP regulations.
• Experienced in GMP audits, including drug product manufacturing and analytical testing sites.
• Ability to build collaborative relationships and lead effectively in a cross-functional environment.
• Self-motivated and results-driven leader with a proactive, hands-on approach.
• Strong organizational, prioritization, and time management skills, coupled with strong critical-thinking abilities to evaluate complex challenges, solve problems effectively, and drive continuous improvement.
• Strong project management skills.

• Excellent written and oral communication / presentation skills.
• Adept at and comfortable with statistical analysis.

Pay Range: $150-190K base (this reflects our reasonable and good faith estimate of what will be paid at the time of posting). Competitive benefits package included.