Job Description

INTERVIEWS: Wednesday, Thursday, Friday 10a-12 & 3p-4 PST (Please put availability on top of resume)

• 2 positions available
• Candidate will be fully remote
• Open to any time zone
• Candidate will managing a system validation, not individuals
• 5+ years of QA with emphasis of computerized system validation
• Must have QA experience, Compliance experience, & Computerized system validation *
• Pharma & Biotech experience must have Review validation/qualification packages for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Bring critical exceptions or deviations to management’s attention and initiate and enforce necessary improvements and corrections to established systems and processes. Initiate, execute, and track completion of Change Control and Non Conformance requests related to computer systems. In support of client Quality Assurance program manages and oversees the operations of a specific area(s) of responsibility FUNCTIONS

1. Responsible for hiring, training, supervising and performance management of staff.
2. May perform or oversee the following functions: a) Review and approve product MPs b) Approve process validation protocols and reports for Mfg. processes. c) Approve Environmental Characterization reports d) Approve planned incidents e) Represent QA on NPI team f) Lead investigations g) Lead plant audits, participate in site audits h) Approve change-over completion g) May perform work of QA Specialist EDUCATION/LICENSES Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources. COMPETENCIES/SKILLS • Project management skills • Strong organizational skills, including ability to follow assignments through to completion. • Initiate and lead cross functional teams. • Collaborate and communicate with higher level outside resources. • Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and process development. • Strong communication (both written and oral), facilitation, and presentation skills. • Strong skill in working independently and to effectively interact with various levels. • Ability to lead and influence staff outside own organization. • Ability to motivate staff and manage and distribute work loads. • Able to manage performance issues and conflict • Ability to provide direction and establish goals for individual staff members and work group. • Ability to evaluate documentation/ operations according to company and regulatory guidelines • Ability to interact with regulatory agencies • Demonstrate the client Values/Leadership Practices Preferred Qualification •Available to work in 2nd shift and non-standard shift.?

Qualifications

Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience.  

Additional Information

TOP 3 MUST HAVE SKILL SETS:

Regulatory Compliance (GxP experience) Quality Assurance experience Computerized system validation experience Within pharma or biotech