Innovative pharma/biotech company with a robust and diversified late stage pipeline of innovative products in rare disease. Company specializing in the research, clinical development, and near future commercialization of rare disease with many of the drugs being developed will be the first and only approved treatments for the diseases and conditions that they target.
Possess exemplary leadership, deep technical, cGMP compliance, and business experience in pharmaceutical quality operations for both quality assurance and quality control functions. This person demonstrates capabilities in execution of cost effective, risk-based, and compliant quality assurance, compliance programs and systems in support of the company infrastructure as well as our external collaborations in order to fully support company drug development and commercial manufacturing activities.
- Implement procedures and systems to ensure overall GMP compliance. Incorporate FDA Regulations guidelines to monitor and control the quality of the drug substance and product.
- Oversees all quality standards for investigational and commercial drug products manufactured while maintaining compliance with regulatory requirements as well as compliance with the GMP standards.
- Represents company as the primary quality interface with business and system related issues at contract manufacturing and laboratory organizations (CMOs).
- Fosters an environment of compliance and operational excellence.
- Leads external staff and stakeholders in all areas of quality operations:
- FDA inspection readiness
- Batch production and packaging record review, revision disposition, review and approve process deviations.
- Implements requirements and guidelines for supplier quality selection, qualification, performance tracking, and reviews for contract manufacturers and testing laboratories.
- Follow-up and approval of Vendor Change Controls and ensure that regulatory impact of these changes is evaluated.
- Develop and implement Quality Agreements with Company Major Suppliers.
- Conduct Supplier GMP audits to ensure compliance to GMPs and Quality Agreement and follow-up to ensure CAPA plans are developed and implemented in timely manner.
- Assist in company compassionate use program.
- Develops Quality Management System directly, and provides oversight and disposition quality excursions, OOT’s, OOS’s, etc., as may impact products from 3rd party manufacturers and laboratories.
- Applies appropriate performance metrics related to the execution of the firm’s Quality operations mission.
- Review and approve IQ/OQ/PQ and validation protocols and reports for all manufacturing, testing, and packaging activities at all CMO’s.
- Executing, analyzing, reviewing and providing recommendations from the firm’s CAPA system, in concert with other functions and/or 3rd parties.
- Investigate technical product complaint issues.
- Coordinate all requests for changes from other departments that improve quality to processes, materials, specifications, facilities and systems for drug substances and products.
- Maintain medication blinding information for various clinical studies, review and approve packaging specifications, batch records for clinical studies.
- Review and justify if appropriate temperature excursions during shipment to the study sites.
- Review stability data and if appropriate issue memorandums to extend the shelf life of clinical batches as per the stability guidance documents.
- Maintain Clinical Trial Application (CTA) information for clinical trials in progress.
- Applies risk management principles into the management and decision-making process, while promoting quality awareness and continuous improvement.
- Maintain SOP training records for all employees, ensure that new employees are trained in core company policies and procedures.
- Maintain a data base with current company policies, Procedures, Working Instructions and ensure that current versions are available for review and for training.
- Complete all company and job related training as assigned within the required timelines.
- Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
- BS/MS/PhD in appropriate scientific discipline, 12+ years of pharmaceutical industry executive quality/compliance responsibilities, with demonstrated & progressively greater achievements in:
- Capable of overseeing and managing large amounts of data with keen attention to detail
- Experience with building a highly effective comprised of internal and external stakeholders
- Quality Systems for both commercial and clinical programs with implementation experience and improvement
- Progressive quality compliance while optimizing cost effective approaches
- Budgeting and department cost oversight
- Experience with multiple sights and diverse 3rd party contract laboratories & manufacturing partners
- Experience providing QA/QC leadership with cross-functional project teams
- Exemplify strong organizational and interpersonal skills and critical thinking and problem solving skills.
- Effective leadership skills and influencing skills, capable of interacting with a wide range of stakeholders and personalities
- Experience with a wide range of dosage formats: injectables, oral solids, small molecules, and creams/Gels
- Proven ability to operate successfully in a rapidly growing organization where the role is both strategic and tactical
- Displays great courage to do what’s right even under challenge by others
- Complete knowledge of the drug development process
- Possession of a mature thinking style is imperative, allowing him/her to formulate solutions from a broad perspective
- Demonstrated effectiveness in collaborating and partnering with others to drive projects
- Being able to command an executive presence in dealing with complex issues and resolve challenges and conflict
- Ability to deal with ambiguity and the ability to make timely, high-quality decisions
- Strong working knowledge of medical regulations
- Strong organizational, interpersonal, and negotiation skills
- Demonstrated ability to manage staff performance and development
- Project management skills
- Strong communication skills (verbal and written) as well as strong listening skills
- Software skills should include MS Office suite
up to $200K+ plus 20-30% Annual Bonus + Incentives
New Jersey or Greater Chicago Area
No, not at this time.
Pl - 8454