1 день назад
Deputy Director of DS Manufacturing Quality Systems
113 250 - 163 583$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Deputy Director of DS Manufacturing Quality Systems (Biopharma Quality): Leading the full lifecycle of drug substance manufacturing quality records, including deviation investigations, CAPAs, effectiveness checks, periodic reviews, and QMS document updates with an accent on cGMP compliance, audit readiness, and cross-functional quality operations. Focus on making risk-based closure decisions, defending quality records during inspections, developing the Quality Systems team, and driving process improvements that reduce deviations and cycle times.
Location: Pearl River, NY; US and Puerto Rico residents only
Salary: $113,250–$163,583 per year
Company
is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines for patients worldwide.
What you will do
- Lead and develop the Drug Substance Manufacturing Quality Systems organization, including Principal Investigators, Technical Writers, and Quality Systems Support Associates.
- Own the timely closure of deviation investigations, CAPAs, effectiveness checks, periodic reviews, and other quality records.
- Review minor, major, and critical events, approve records before Quality Assurance review, and maintain accurate QMS documentation.
- Coordinate with Manufacturing, Quality Control, Manufacturing Technology, Sterility Assurance, and Quality Assurance to resolve roadblocks and build consensus.
- Represent the site during internal and external audits and regulatory inspections, defending investigation reports and quality documentation.
- Drive process improvements, new tools, and cost-reduction initiatives that reduce deviations and improve Quality System cycle times.
Requirements
- Bachelor’s degree in Life Sciences, Engineering, Business, or a related field.
- 7+ years of experience in a cGMP-regulated pharmaceutical or quality environment.
- Experience leading cross-functional quality systems initiatives, projects, or programs.
- Ability to make independent risk-based decisions and manage multiple high-priority deadlines.
- Strong consensus-building, written communication, verbal communication, and stakeholder-influence skills.
- Ability to work extended and flexible hours, including weekends, as business needs require.
Nice to have
- Experience managing direct reports or technical teams in a regulated environment.
- Experience leading quality systems, project teams, or independent contributors.
Culture & Benefits
- Supportive, future-focused environment with career growth through promotion or lateral opportunities.
- Rewards package recognizing employee contribution.
- Healthcare, prevention, wellness, and family benefits, including at least 14 weeks of gender-neutral parental leave.
- Opportunities to work with digital, data, and AI-driven innovation in medicine and vaccine delivery.
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