Nationwide Executive Recruitment From FPC

(F-O-R-T-U-N-E PERSONNEL CONSULTANTS)

You'll Value The Experience!

JOB DESCRIPTION

The Quality Project Manager supports new technology acquisitions and new product introductions by serving as the quality representative on biologics project teams.

This person ensures that the research, design, development, and production processes comply with internal standards, CFR and other applicable standards and regulations.
The Quality Project Manager supports technology transfers by interacting with internal teams and contract groups. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Serve as a project team member on New Product Development project teams by representing the Quality organization.

Create, review and approve technical documents including but not limited to SOPs, quality and validation master plans, equipment qualifications, inspection procedures and technical protocols.

Serve as “quality” interface with contract manufacturing organizations (CMO) with respect to quality activities. 

Serve at technical subject matter expert for biologics manufacturing in the areas of technology transfer, validation and facility qualification.

Develop and maintain a Quality System specific to Biologic and/or Combination products.  Support product registration of Biologic/Combination products to FDA and other Governmental Authorities.

Coordinate meetings to review all quality aspects of products.  Interface with Team Members to ensure quality considerations from the concept stage through commercialization. 

Ensure that deliverables comply with applicable standards/regulations and Smith & Nephew requirements.

Responsible for quality issues escalation and resolution to maintain the flow of products and documents.

Responsible for the Risk Management process per ISO 13485 and ISO 14971 for biologics and combination drug and device projects.

Work with suppliers to resolve quality issues via CAPA program and monitor suppliers’ manufacturing capabilities to ensure delivery of conforming products.

Facilitate regular quality meetings with suppliers and team members.

Provide support during technical due diligence assessments, internal and external audits, and regulatory inspections.

Responsible for quality control/quality assurance staff development programs.

Complies with all health, safety and environmental policies, procedures and job hazard analyses applicable to specified job activities; including medical evaluations as required by job function.

Completes all required HSE training.

 REQUIRED EXPERIENCE

Bachelor degree in a science/technical field such as Pharmacy, Biology, Molecular Biology, Cell Biology, Microbiology, Chemistry or Engineering.

Three to five years working in a medical device, pharmaceutical, or biologics environment.  Experience with obtaining regulatory approval of tissue, combiniation or Orthobiologics products is preferable.

Experienced lead auditor plus certification as lead auditor by national body such as ASQ or ability to obtain certification within 6 months of job acceptance.

Experience with supporting process validation and technical transfer team to ensure validation readiness to support production, license preparation and pre-approval inspection activities.

Working Experience preferred:

aseptic filling

lypholization

fermentation processing

genetic engineering (gene expression)

emulsification

peptide chain manufacturing

YEARS EXPERIENCE: 5+ to 7 years

TRAVEL: 25%