Site Head of Quality

Sebela Pharmaceuticals•Holbrook, MA

8d•$200 - $270

About The Position

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. The Site Head of Quality provides leadership, direction and quality oversight for our Holbrook manufacturing site. This position is responsible for the development, implementation and maintenance of quality assurance systems and activities and will collaborate closely with team members at all levels to ensure compliance with all relevant cGMP regulations and guidelines. This individual will provide QA expertise and guidance in support of the development and product quality strategy and will be responsible for execution of the day-to-day quality activities. This role reports to the Chief Operating Officer.

Requirements

Bachelor's or master's degree in chemistry, biology or pharmacy
10+ years of experience working in pharmaceutical product manufacturing with experience in compliance, and quality assurance.
Direct experience interacting with U.S Food and Drug Administration and other regulatory agencies.
Strong knowledge and understanding of FDA cGMP regulations.
Experience with and fundamental understanding of FDA regulations and guidance documents.
Experience leading GMP audits, and hosting on site FDA inspections covering drug product manufacturing and analytical testing sites.
Understanding of process validation and/or IT compliance.
Experience in defending processes, procedures and investigation during regulatory inspections.
Strong interpersonal, communication and influencing skills.
Ability to foster excellent working relationships across all levels within the organization.
Highly effective leadership skills with demonstrated success in building high-performing teams.
A true self starter, who works effectively on their own initiative, and is used to working in demanding environments with continuous change and ambiguity.
Strong problem-solving ability to evaluate quality matters and make decisions utilizing risk-based approach.

Nice To Haves

CDMO experience preferred but not required.

Responsibilities

Effectively manage resources within Quality department in a manner that supports the delivery of the company’s goals and objectives for regulatory compliance and product quality.
Implement and maintain a Quality Management System (QMS) that operates effectively.
Provide strong leadership and support to quality team members ensuring a collaborative, positive team environment.
Monitor manufacturing operations for compliance to regulations, SOPs and batch records.
Ensure products are always manufactured according to batch records and within cGMPs.
Ensure the site maintains a state of ‘continuous’ regulatory inspection readiness, including preparation for, participation in and follow up on inspections by regulatory authorities.
Interact with CDMO customer contacts on quality and operational matters.
Verify manufacturing operations are following Good Manufacturing Practices (GMPs), as outlined in the CFR, FDA Guidance Documents, ICH guidance documents.
Coordinate resolution of vendor related issues.
Review and approve manufacturing protocols, qualifications, and summary reports.
Collaborate with the investigations department to ensure quality related issues are resolved thoroughly, in a timely manner, and incorporate cross functional processes to determine root cause.
Participate in internal and external audits.
Analyze data to identify areas for improvement in the quality system.
Other duties as assigned.