Contract Position-24-30 months
Send resumes to: bciociola@covexllc.com

1. Supports the Consent Decree WorkPlan activities.
a. Ensure the site procedures reflect the roles identified in the Process Remediation Step. Validate the QA roles being proposed by the specifically assigned QSE teams and ensure organization alignment with QA function.
b. Coordinate QA Resources within assigned QSE Teams as needed with Site CD and QACD Management.
i. Ensure adequate QA resources are available to meet the demands that will be generated from the QSE work plan (QA reviewers, QA approvers, doc management, change control, etc.). Escalate to QA CD Site Lead for resolution as needed.
ii. If resources need to be pulled from Base Business, escalate to QA CD Site Lead for immediate resolution.
c. Provide QA representative for each specifically assigned QSE team.
i. Participate as a fully embedded member of the assigned QSE teams, and ensures that the compliance requirements are met in the execution of the plan by ensuring access to QA for guidance and appropriate GMP content.
ii. Provide QA documentation review and approval prior to verification.
2. Ensures that individual CD WorkPlan work streams for specifically assigned QSE Teams are properly coordinated at the site level for efficient and compliant implementation and integration into the site quality systems and associated business systems.
3. Partner with Quality, Operations and other GMP and non-GMP functional area leadership and team members at the site to clarify requirements, boundaries and expectations of assigned WorkPlan steps.
4. Ensures consistent practices are in place and aligned throughout the site.
5. Provide guidance to the QSE teams relative to GMP compliance and industry best practices in Quality Assurance and Control in the following areas:
a. SOP clarity and reflection of requirements in the Company Quality Standards, Enterprise Quality Standards and GMP’s
b. Assure that the SOP’s and associated revised processes comprehensively address findings traced to the Numbered Step and /or Quality System Element from the Quantic Baseline Inspection.
6. Assure Good Documentation Practices are followed
7. Must have very good interpersonal skills, be a collaborative team player, and be able to work in a matrixed and cross site, cross QSE environment.

Education:
Bachelor's Decree in Physical Sciences, Engineering, or a related discipline

Experience/Technical Competencies:
Miminum of 8 years of relevant experience with increasing resonsibility in the pharmaceutical or medical device industry. Direct factory or plant experience in Operations, Quality, or Engineering. Direct experience in assessment/development of GMP compliant methodologies Masters degree or other advanced decree preferred.
Experience with Quality System Design and Imlementation, GMP Audits, Quality Assurance Management Experience within a GMP manufacturing facility.

Job Knowledge/Skillsets:
Required Skills/Abilities: Excellent written and oral communication skills; strong influencing and negotiating skill without direct line authority; proven record of leading teams in delivery of results. Ability to manage change effectively and deliver timely decisions with minimal information; process orientation and ability to evaluate issues from a work flow perspective; experience in a medical device or pharma regulated environment. Fluency in Spanish is desirable.

Travel:
<10%

Contract Length:
24-30 months