Quality Assurance Technical Lead Jobs

Working with regulatory affairs to understand, interpret and agree on suitable CMC submission strategies for the life-cycle management of approved products.

Management and execution of sustainable performance improvements

Prepare and present project update reports to senior management as required

Apply pharmaceutical operational and quality knowledge to highlight inter-process, systems and capability relationships and related activities that require improvement

Previous experience working with FDA and participating in regulatory agency inspections

Extensive experience in quality, manufacturing or MS&T departments of a commercial pharmaceutical manufacturing company

Support with asset development, review, and support requests spanning meeting, action plans, change management, information requests, sample evidence, asset population.

Highly responsive & adept at queue management with flexible hours - may require later PST hours

Work with key stakeholders including privacy, product and others to understand QA & content requirements

Quality/Content Analyst Experience (3+ years)

Proven ability to manage multiple work streams at a time with high attention to detail

Remote candidates in PST time zone strongly preferred.

Participation and knowledge of the progress relating to all ongoing digital transformation products

Understands the key principals of Excess & Surplus lines insurance, the ideal candidate will have prior underwriting experience

Prior experience leading projects, project teams a plus

Health benefits & 401K with employer match

Employer paid continuing education courses and designations

Validation of forms and policy proofing for production offices that have recently been onboarded in relation to new product rollout

Vacation, sick time and holidays

Volunteer time to participate within your community

Paid sabbatical after 5 years; every 3 years thereafter

Here’s What You’ll Bring to the Table:

Generous paid time off, including:

Review and test products regularly and effectively to ensure that they meets quality and regulatory requirements

Assist the Director of Privacy & Security with general office duties including ad hoc research, data entry, and organizing documents

Working remotely in a start-up or small business environment

Lived and/or professional experience with vulnerable adult populations strongly preferred

Strong written and verbal communication skills

1 - 2 years of experience:

Experience controlling test environments and configuration management

Experience working with Environments and Release Management with large scale transformations a plus.

Experience controlling test environments and configuration management.

MINIMUM KNOWLEDGE, SKILLS & ABILITIES REQUIRED:

Bachelor’s degree in a relevant technology field or equivalent combination of education and work experience.

Experience with the concept of using API’s for Integrations