Emergent BioSolutions is currently seeking a Sr Manager / Director, GXP Compliance who is quality focused with a proven ability to work in a fast-paced and highly regulated environment. We are looking for an individual who is a team player and motivational leader. The successful candidate will possess a strong work ethic with a commitment to excellence, innovation, and a drive to lead our organization towards success.
Emergent BioSolutions is dedicated to one simple mission—to protect and enhance life. As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats.
We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.
the Senior Manager / Director, GXP Compliance supports the Quality team by providing leadership to a team of quality auditing and compliance personnel with the primary objective of supporting and regularly assessing GXP compliance of the Winnipeg Site. This is accomplished by providing leadership to the GXP compliance team, by establishing and managing quality systems that ensure proactive implementation of systems and system changes to meet changing regulatory demands, and by leading the site internal audit function which ensures that all site activities are conducted in full compliance with GXP requirements.
The Senior Manager / Director is additionally responsible and accountable for providing Quality Assurance oversight to certain specialized functions within the site including Pre-clinical (GLP), Clinical (GCP), and Pharmacovigilance (GVP) operations, as well as Plasma Supply Quality.
DUTIES & RESPONSIBILITIES
- Provides leadership to the GXP compliance team by selecting, developing, coaching, and mentoring team members to function as Quality & Regulatory Compliance Subject Matter Experts.
- Provides Quality and Compliance leadership to the site through the management and execution of quality and compliance systems (e.g. site compliance audit program, local execution and coordination of global SQM program including responsibility for execution and maintenance of supplier quality agreements; development and maintenance of CMO quality agreements; coordination of compliance programs with Global Quality, data integrity and Customer Inquiries process).
- Identifies, prioritizes, and communicates compliance risks to Site Leadership Teams.
- Coordinates and participates in processes and activities with Global Quality initiatives.
- Surveys regulatory and industry trends, regulations, and guidance and develops plans to facilitate the implementation of appropriate systems throughout the site.
- Develops and manages department budget.
- Provides regulatory compliance support to the site through:
- Management of the Winnipeg site internal audit program
- Preparation for and management of GMP regulatory and customer inspections
- Assisting Operational groups in preparing for and management of regulatory inspections, and in particular those relating to GLP, GCP, and GVP regulated operations
- Review of responses to regulatory inspections from other Emergent sites to determine potential impact to Winnipeg site
- Development and review of regulatory inspection corrective action responses to ensure they adequately address the observations in a timely manner, and in particular those relating to GLP, GCP, and GVP regulated operations
- Tracking and trending of regulatory inspectional observations
- Develops and mentors staff, providing strategic leadership while simultaneously providing opportunities for growth and professional development
- Quality Assurance support to GLP regulated operations through the assessment of GLP related changes to procedures, protocols, and study reports and through the conduct of facility and study-related audits. This includes ensuring that Test Site Management, Study Director and/or Principle Investigators are informed of compliance issues related to GLP studies and associated facilities
- Quality Assurance oversight to GCP regulated operations through the review and approval of related changes, procedures, deviations and corrective action plans, and review of clinical study materials including investigators brochures, study protocols, and study reports. Establish appropriate audit plans and conduct site and study-related GCP compliance audits
- Quality Assurance oversight to GVP regulated operations through the review and approval of related changes, procedures, deviations and corrective action plans. Establishes appropriate audit plans and conducts internal and vendor-related compliance audits
- Provides direct quality oversight for external plasma supplies and vendors.
- GXP Duties include:
- Ensures compliance with the requirements of current Good Manufacturing Practices (cGMP).
- Responsible for providing adequate resources including personnel, equipment, facilities, and materials for GXP Compliance. Approves, selects, and monitors contractors/analysts in the department.
- Performs or delegates the initial and continuing training of personnel in GXP Compliance.
- Aids management with regulating procedures/processes pertaining to Quality Compliance.
- Establishes, implements, and maintains departmental procedures consistent with company policies and standards for hygiene, safety, and security to assure compliance with applicable regulations, guidance documents, and industry best practice.
- Identifies, investigates, and reports to management issues which may affect product Safety, Quality, Identity, Purity, or Potency (SQIPP).
- Investigates Quality System deficiencies as required.
- Manages all product related complaints as per approved procedures.
- Manages and maintains Emergent’s self-assessment program and supplier management program.
- Manages and supports all regulatory and customers’ inspections. Coordinates responses to all inspection observations.
- Manages the work activities of staff to ensure implementation of quality and compliant systems.
- Provides input with required validations.
- Reviews and approves validation protocols and reports.
- Possesses authority to delegate the above tasks to trained members of the management team.