Specialist I, External Quality

I.    JOB SUMMARY 

Reporting to the Manager, Quality Assurance, this is an advanced position requiring significant expertise/specialization in area with responsibility for day-to-day implementation of Quality Systems and Compliance functions appropriate for Emergent (EBSI) combination product(s) (devices).

The role is responsible for 1) quality oversight of commercial manufacture in compliance with Good Manufacturing Practice (GMP) requirements 2) executing Quality Management System requirements in support of commercial and developmental programs 3) ensuring the realization of industry best practices for GxP and 4) serving as quality approval proxy as required.

The Senior Quality Specialist will be capable of working on complex issues where analysis requires an in-depth assessment, considering many variables and potential consequences. May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to Emergent products. May assist with compliance audits as required.

II.    ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

•    Responsible for Quality oversight, with management support of external manufacturing, warehousing operations, validation, verification, and quality control of combination product(s) (devices) at Emergent.
•    Responsible for the management of product release, including batch documentation review, management of changes, complaints, deviations, validations, and product annual reviews to ensure completeness, accuracy, and compliance.
•    Co-ordinate with CMO Quality and Operations teams to independently resolve discrepancies while liaising with internal Quality Groups to ensure on-time disposition of Finished Product. 
•    Evaluation and approval of supplier and CMO change notifications. Author and coordinate applicable changes through the Emergent Change Management process as required.  
•    Author, review and approve Quality Related Procedures as required in accordance with Emergent internal procedures and GMP principles to ensure quality objectives are met.
•    Active participation and support implementation of continuous improvement initiatives of External Quality.
•    Provide support and expertise for inspection readiness activities, including internal self-inspection and during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions. 
•    Support the stability program for combination products (devices) as required, facilitating communication and data acquisition between supply chain, contract manufacturers and stability program coordinator.
•    Support the Vendor and Raw Material Qualification Program through collaboration with SQM Group  To facilitate discussions between Emergent and CMO Quality organizations to establish responsibilities for Quality related functions.
•    Provide Quality oversight to Science and Development Team for technology transfer across contract organizations to include; validation/verification activities and Laboratory Investigation Report review and approval for commercial and developing product pipelines.
•    Support regulatory department with any regulatory filings associated with new market authorizations, annual reports and change supplements.
•    Responsible for identifying defects and have the authority to report device / combination product defects at any time.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. 

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
•    Academic degree in Engineering or Science (preferably in an Applied Science). 
•    6 + years’ experience working in international device and pharmaceutical /bio pharmaceutical companies with increased level of responsibility, with at least 2 years in a senior position.
•    Comprehensive knowledge of cGMP, Aseptic Manufacturing and Quality Assurance experience. 
•    Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements.
•    Demonstrates thorough knowledge of FDA / EMEA standards and quality systems. Having interface with or participating in regulatory agency inspections preferred.
•    Ability to deliver in a challenging environment using own initiative with little instruction on routine work, general instructions on new assignments.
•    Strong mature leadership and interpersonal influencing skills showing personal/departmental accountability and responsibility.
•    Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.
•    Ability to operate efficiently in a complex matrix organization and international environment making sound decisions regarding compliance-related issues with minimal supervision.
•    Ability to lead Change Management activities and strong Project Management knowledge.

IV.     PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.

The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.