Senior Specialist Development Quality Biologics

Senior Specialist Development Quality Biologics

Ensure Biopharmaceutical Development sites are in an audit readiness state

· Provide audit/inspection readiness support to Biopharmaceutical Development including site self-inspections and mock inspections

· Coordinating the review and responses to audit observations and ensuring timely completion of tasks.

· Coordinating regulatory surveillance activities and tasks

· Auditing internal and external - utilizing risk-based strategy.

· Managing training and learning strategy for manufacturing, QA and other related support functions

· Extraordinary communication and interpersonal skills, emphasizing the abilities to know when to lead, collaborate, support, with SMEs and stakeholders

Specific Responsibilities of Role Holder

In addition to the general description of the parent profile role for this job function, the following summarize key result areas, specific accountabilities and / or tasks, etc. associated with this job title include:

· Act as local process champion of Audits and Inspections, and Regulatory Surveillance

· Facilitate risk assessment to ensure consideration of all impacted groups and processes

· Assist in planning and coordinating Corporate, Customer and Regulatory Agency audits/inspections

· Assist in developing quality metrics to present to management on a periodic basis (eg. Monthly and Quarterly Management Reviews)

· Provide support of quality record management in EQV and trending of quality metrics as assigned

· Responsible for managing AZ Quality & Compliance Manual (QCM) site level implementation and gap assessment process

· Coordinate and assist in developing Business Process Management (BPM) in Development Quality Biologic and Biopharmaceutical Development

· May travel nationally/internationally and represent company during audits

· Assist in improving and maintaining a regulatory surveillance program for Development Quality Biologics organization in support of Biopharmaceutical Development including reviewing regulatory documentation for compliance and coordinating gap assessments as needed

· Complete routine archive operations for GLP, GCP and GMP paper records generated at the Gaithersburg site(s) under the supervision of archive personnel in accordance with approved procedures as required.

Education, Qualifications, Skills and Experience

Minimum Essential Experience:

· Experience working in a regulated environment:

  Minimum of 4 years relevant experience

Minimum of a Bachelor; s degree with BS/BA degree

· Knowledge of regulatory requirements (eg. 21 CFR Parts 210, 211, 820; EU Volume 4; PIC/S; ICH; ISO;

Pharmacopoeia)

· Experience following standard operating procedures (SOPs)

· Good listening skills, interpersonal savvy, and peer relations

· Basic understanding and application of GxP principals, concepts, practices and standards

· Able to apply and manage risk management philosophy

· Excellent computer skills, including a high level of comfort with web-based programs in addition to the

standard office applications (MS Office, Internet applications, etc.) and understanding of electronic

systems such as controlled document/training/compliance systems

· Ability to transfer knowledge: developing training materials and conveying complex concepts

· Strong analytical and organizational skills and the Flexibility to handle multiple tasks and deadlines

· Demonstrated experience with regulatory and/or internal audits and inspections

Desirable Experience:

Experience coordinating audits and site audit readiness activities

Experience in production or quality support of Cell Therapy, Device, ADC, Development Labs

· Experience developing and running metrics

· Understanding and use of Microsoft Power Platform (Power Automate, Power Apps, Power BI)

 · Understanding and use of LEAN and/or Operational Excellence (FMEA, DMAIC, root cause analysis etc.) concepts

 · Application of risk-based strategy

· Knowledge of adult learning, participatory methods, blended learning, experiential learning and other instructional design approaches

The annual base pay for this position ranges from $123,678.40 - $185,517.69 either as a salary as the hourly rate (annual salary divided by 2080 hours)]. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate i