Director, Quality Compliance
EyePoint
2 months ago
Remote friendly (Northbridge, MA)
United States
$193,640 - $244,453 USD yearly
Operations
Responsibilities:
- Manage the Quality Compliance team and lead harmonization initiatives to globalize quality compliance processes across GxP functions.
- Partner with Quality Assurance functional leads to ensure compliance across all functions.
- Define Quality Compliance objectives and ensure cross-functional progress and completion.
- Provide leadership, guidance, and direction to staff consistent with GxP guidance.
- Foster a compliance-focused environment and drive continuous improvement.
- Own the vendor and supplier management Quality program across clinical and commercial programs, aligned with global regulatory expectations (FDA, EMA, ICH, etc.) supporting R&D, clinical affairs, and technical operations.
- Oversee external vendor oversight processes (e.g., Qualification/Requalification, Quality Agreements, Periodic Review, Approved Vendor/Supplier List Maintenance, SCARs).
- Perform regulatory surveillance of vendors/suppliers.
- Oversee and enhance the internal audit program; conduct external and internal audits as needed.
- Oversee and scale global processes for product quality complaints, field alert reporting, investigation closure, and post-market reporting compliance.
- Lead and/or participate in inspection readiness efforts across GxP functions (e.g., FDA BIMO, PAI, routine), including hosting plan and SME preparation.
- Represent Quality Compliance during regulatory inspections.
- Notify/escalate potential quality compliance concerns to Quality Senior Management.
Qualifications:
- Minimum 15+ years’ experience in the pharmaceutical/biotech industry.
- 3+ years of GxP leadership experience managing internal teams.
- Bachelors or advanced degree in a scientific discipline.
Required skills/knowledge:
- Strong collaboration and influencing skills across diverse functions and organizational levels.
- Excellent verbal and written communication; detail-oriented; ability to drive change across functions.
- Expert in interpreting guidelines and regulations (FDA, ICH, EMEA, etc.).
- Experience interacting with regulatory health authorities at pre- and post-approval inspections.
- Ability to evaluate Quality Programs and drive value-added enhancements.
- Solution-oriented team player with a customer service approach.
- Ability to work individually and within multidisciplinary teams and with external partners/suppliers.
Other requirements:
- Travel up to 10–15% to support vendor/supplier audits.
- Experience in multi-GxP areas preferred (GMP, GCP, GLP).
- Manage the Quality Compliance team and lead harmonization initiatives to globalize quality compliance processes across GxP functions.
- Partner with Quality Assurance functional leads to ensure compliance across all functions.
- Define Quality Compliance objectives and ensure cross-functional progress and completion.
- Provide leadership, guidance, and direction to staff consistent with GxP guidance.
- Foster a compliance-focused environment and drive continuous improvement.
- Own the vendor and supplier management Quality program across clinical and commercial programs, aligned with global regulatory expectations (FDA, EMA, ICH, etc.) supporting R&D, clinical affairs, and technical operations.
- Oversee external vendor oversight processes (e.g., Qualification/Requalification, Quality Agreements, Periodic Review, Approved Vendor/Supplier List Maintenance, SCARs).
- Perform regulatory surveillance of vendors/suppliers.
- Oversee and enhance the internal audit program; conduct external and internal audits as needed.
- Oversee and scale global processes for product quality complaints, field alert reporting, investigation closure, and post-market reporting compliance.
- Lead and/or participate in inspection readiness efforts across GxP functions (e.g., FDA BIMO, PAI, routine), including hosting plan and SME preparation.
- Represent Quality Compliance during regulatory inspections.
- Notify/escalate potential quality compliance concerns to Quality Senior Management.
Qualifications:
- Minimum 15+ years’ experience in the pharmaceutical/biotech industry.
- 3+ years of GxP leadership experience managing internal teams.
- Bachelors or advanced degree in a scientific discipline.
Required skills/knowledge:
- Strong collaboration and influencing skills across diverse functions and organizational levels.
- Excellent verbal and written communication; detail-oriented; ability to drive change across functions.
- Expert in interpreting guidelines and regulations (FDA, ICH, EMEA, etc.).
- Experience interacting with regulatory health authorities at pre- and post-approval inspections.
- Ability to evaluate Quality Programs and drive value-added enhancements.
- Solution-oriented team player with a customer service approach.
- Ability to work individually and within multidisciplinary teams and with external partners/suppliers.
Other requirements:
- Travel up to 10–15% to support vendor/supplier audits.
- Experience in multi-GxP areas preferred (GMP, GCP, GLP).