Emergent BioSolutions is currently seeking a Sr. Manager, GXP Compliance. The successful candidate will have a University Degree in a Science related filed, 8 years of broad GXP compliance related experience and 5 years of progressive management experience. The ideal candidate will have a solid working knowledge of FDA, Health Canada and EMA GXP regulations and have excellent written and verbal communication. In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.
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.
Reporting to the Director of Quality Assurance, the Senior Manager, 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 is also responsible and accountable for providing Quality Assurance oversight to Plasma Supply Quality and stability.
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; development and maintenance of CMO quality agreements; coordination of compliance programs with Global Quality and data integrity).
- Identifies, prioritizes, and communicates compliance risks to Site Quality Management.
- 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.
- Coordinates the preparation of Product Annual Reviews
- Develops and manages department budget.
- Provides regulatory compliance support to the site through:
o Management of the Winnipeg site internal audit program
o Preparation for and management of GMP regulatory and customer inspections
o Review of responses to regulatory inspections from other Emergent sites to determine potential impact to Winnipeg site
o Development and review of regulatory inspection corrective action responses to ensure they adequately address the observations in a timely manner, Tracking and trending of regulatory inspectional observations
- Provides Quality Assurance support to site GLP test lab.
- Provides direct quality oversight for external plasma supplies and vendors.
- 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 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.
- Possesses authority to delegate the above tasks to trained members of the management team.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
EDUCATION, EXPERIENCE & SKILLS:
- Minimum University Degree in a Science related field.
- Minimum 8 years broad GXP compliance related experience.
- Minimum 5 years of progressive management experience.
- Experience in Pharmaceutical or Medical Device industry is preferred.
- Previous auditing experience and a broad understanding of GXP compliance programs is required.
- Experience interpreting regulatory requirements in the light of current guidance and international regulatory body field activity is required.
- Experience in communication of requirements and regulatory issues are required.
- Hands-on experience interacting with regulatory authorities is required.
- Solid working knowledge of FDA, Health Canada and EMA GXP regulations.
- The ability to be detail and goal oriented, focused on teamwork and the customer, prioritize and adapt to business needs is required.
- Excellent written and verbal communication, influencing and negotiating skills are required to inspire trust and quickly build credibility within the Quality and Compliance community.
- Strong consultant and leadership skills are required.
- Citizenship/Permanent Resident or Valid Work Permit.
- Successful Completion of a Criminal Record Check.
INTERESTED? Please visit www.emergentbiosolutions.com under careers to apply today!