Executive Director - Quality, GMP
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The Executive Director - Quality, GMP is responsible for developing, implementing, maintaining and assuring compliance with Good Manufacturing Practices at the Acorda Chelsea/Waltham facilities and associated outsourced operations with respect to both product development and commercialization activities for drug and combination products.
The Executive Director - Quality, GMP is responsible for developing, implementing, maintaining and assuring compliance with Good Manufacturing Practices at the Acorda Chelsea/Waltham facilities and associated outsourced operations with respect to both product development and commercialization activities for drug and combination products. This individual also provides strategic perspective and direction based on expert and up-to date understanding of GMP quality systems and industry best practices for both site and corporate quality initiatives.
*Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Assures that Acorda development and commercial drug and combination products are manufactured and distributed in accordance with Good Manufacturing Practices (GMP)
- Cultivates a phase-appropriate and risk-based quality system approach to GMP
- Provides strategic direction to address compliance gaps and improvements to the Acorda Quality Management System (QMS)
- Develops a skilled and highly motivated site Quality Assurance organization, including resource planning, talent acquisition, training and mentoring, goal setting, ongoing feedback, performance review and personnel development
- Oversees site QA functions, including:
- Quality Systems, including approval and archiving of Standard Operating Procedures and GMP-controlled documents
- Audit and Supplier Quality, including quality agreements, preapproval inspection (PAI) readiness, device (inhaler) design and manufacturing oversight, product complaint investigation, GMP training, internal and supplier audits, quality metrics and management reviews. Solid understanding of EMA regulations and working with European Suppliers.
- Quality Operations, including real time shop floor inspections, raw material release, line clearance, batch record and analytical data review, stability program oversight, work in process (WIP) and finished product release, review of manufacturing and laboratory investigations, environmental monitoring, and annual product review.
- Validation, including change control ownership and validation oversight (facility, equipment, manufacturing process, process control systems, computer systems and equipment cleaning)
- Ensures that investigations into failures, deviations and discrepancies properly address root cause, product impact assessment and appropriate corrective and preventive actions (CAPA)
- Develops and maintain the site QA operating budget
- Hosts regulatory health authority inspections and leads inspection readiness efforts
- Represents Quality GMP on project teams
- Ensures that quality system metrics and trends as well as compliance issues and their resolution are tracked and presented to management with executive responsibility on a timely basis
Education and/or Experience:
- Bachelor’s degree in life sciences or related field required.
- Master’s degree in life sciences or related field preferred.
- Demonstrated competence in hosting health authority inspections required.
- Minimum of fifteen - twenty years’ experience in GMP quality assurance roles with advanced delivery system technologies.
- Minimum of ten years experience in a GMP leadership role.
- Prior experience with pharmaceutical, combination products and biological products as well as with medical devices highly preferred.
- Prior domestic and international experience preferred.
- Experience with clean room environment control highly preferred.
- This individual supervises 20 associates; 4 direct reports in the Quality department.
- Expert knowledge of CGMP
- Expert knowledge of medical device regulations
- Strong knowledge of 21 CFR Part 11 (Electronic Records; Electronic Signatures) and equivalent international regulations
- Strong knowledge and understanding of the approach and perspectives of regulatory agencies.
- Strong knowledge of GEP (Good Engineering Principles), validation requirements and ISPE standards.
- Must be able to interpret and apply existing and new/revised CGMP regulations and guidance independently.
- Extensive knowledge of FDA, EMA and ICH CGMP requirements and guidance regarding CGMP (clinical supplies and commercial product), product complaints, field alerts, and investigation.
- Extensive auditing experience with outside vendors (domestic and international).
- Strong negotiating skills working with quality agreements/contracts.
- Must be proficient in MS Office Suite.
- Familiarity with electronic systems and the requirements for their validation, for example, electronic document management, electronic quality management systems, learning management systems, building and process automation systems, analytical laboratory software, inventory management systems, and calibration and preventative maintenance software.
Certificates, Licenses, Registrations: none required
Other Skills and Abilities:
- Excellent writing, communication and presentation skills.
- Ability to manage both day-to-day operations as well as project work in a fast paced environment.
- Ability to work both independently and in a collaborative team setting.
- Ability to multi-tasks and adjust priorities, as necessary.
- Ability to effectively present information to management.
- Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.
- Demonstrated leadership and project management skills.
- Demonstrated understanding and experience working with international cultures.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- This position requires travel; the average travel for this position is 35% with some variation based upon the demands of the business imperatives. Travel is to both domestic and international locations in support of quality assurance activities.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
No specific work demands.
*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.