Job Description :
Need Project Manager
Location: Westlake, CA
Duration: 6 months+
Rate: Open on c2c or 1099 all inc

The purpose of this role is to provide Quality support/oversight of artwork management/labelling change process to ensure clear requirements are defined and executed to enable release of artwork to CMO/print vendor.

85% Support/oversight of the artwork management/labeling change process to ensure clear requirements are defined and executed to enable release of artwork to CMO/print vendor.
5% Support resolution on areas identified as non-conformance related to his/her area(s) of expertise, as requested
5% Support gathering quality metrics
5% Support department activities as needed

Education and Experience Requirements
Include educational requirements or equivalency, required years and type(s) or experience, and necessary licenses or certificates. Specify which are required and which are preferred. For UK, please do not use years of experience due to UK Legislation
Bachelor’s degree
?2 years in pharmaceutical manufacturing/quality operations
Packaging and labeling experience

Key Skills, Abilities, and Competencies
Describe critical skill and abilities needed to successfully perform the job, which should be representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
General knowledge of FDA regulations and GxPs
Must be self-driven and have the ability to operate with limited direction
Interpersonal skills including ability to build authentic relationships, cooperate as a team member and share information with a team
Must be detailed oriented, have the ability to meet deadlines, and have good communication skills
Adopt and exemplify the Shire leadership behaviors: Be positive, Be accountable, Be results driven and Be an excellent manager of self and others

Complexity and Problem Solving
Describe the decisions made by the incumbents on a regular basis. Include decisions within the Incumbent’s authority to make as well as those decisions that must be referred to a higher level.
Exercises judgement within defined procedures and practices to determine appropriate action
Provides input to the Artwork and Labelling Quality Lead to make decisions regarding overall Quality strategy and priorities
Escalate quality issues to the Artwork and Labelling Quality Lead when necessary

Internal and External Contacts
List contacts this job advises, consults, or coordinates with on a regular basis. Describe to whom the job is accountable. Indicate each Contact category (Internal, Vendor, Customer, or Other) and provide examples.
Internal: This role is accountable directly to the Artwork and Labelling Quality Lead. Key stakeholders include but are not limited to: Supply Chain, Regulatory, Quality, Packaging Engineering and IT
External: CMOs, consultants, contractors, outsource partners, suppliers