Sebela Pharmaceuticals Inc. · 4 weeks ago
Site Head of Quality
Holbrook, MA
Full-time
Onsite
Director/Executive
$200K/yr - $270K/yr
10+ years expSebela Pharmaceuticals is a U.S. pharmaceutical company focusing on Gastroenterology and Women’s Health. The Site Head of Quality will provide leadership and quality oversight for the Holbrook manufacturing site, ensuring compliance with cGMP regulations and managing day-to-day quality activities.
MarketingMedical DevicePharmaceutical
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
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
Qualification
Required
Bachelor's or master's degree in chemistry, biology, pharmacy
10+ years of experience working in pharmaceutical product manufacturing with experience in compliance, and quality assurance
Direct experience interacting with US 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 with the 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
Preferred
CDMO experience preferred but not required
Benefits
Competitive benefits package included.
Company
Sebela Pharmaceuticals Inc.
Sebela Pharmaceuticals is a U.S. pharmaceutical company with a market-leading position in Gastroenterology and a focus on innovation in Women’s Health.
201-500 employees
H1B Sponsorship
Sebela Pharmaceuticals Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2022 (2)
Funding
Current Stage
Growth StageTotal Funding
unknown2016-01-01Private Equity
Leadership Team
Kelly Culwell
Chief Medical Officer and Head of Research and Development, Women's Health
Recent News
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