Salary

$90k - $100k Per Year

Job Type

full-time

Posted

10 days ago

Location

Lynnwood, WA

Description

job summary:

Seattle based company which is devoted to developing and commercializing cancer medicines and combination therapies that can make a meaningful difference in the lives of cancer patients is actively seeking a professional Senior Manager - Release/CMO Compliance who is willing to relocate to a northern Seattle suburbs - relocation package is part of the compensation for this opportunity. Immediate start date with full benefits package.

Seattle based company which is devoted to developing and commercializing cancer medicines and combination therapies that can make a meaningful difference in the lives of cancer patients is actively seeking a professional Senior Manager - Release/CMO Compliance who is willing to relocate to a northern Seattle suburbs - relocation package is part of the compensation for this opportunity. Immediate start date with full benefits package.

The Quality organization ensures the safety, efficacy, purity, and quality of manufactured products through compliance with cGMPs, regulations and established procedures.

The Quality Assurance Release / CMO Compliance department provides QA oversight of the systems and procedures governing the GMP release activities at the Northpointe facility for API / BDS and at CMO organizations for Drug Product, including the related, supporting processes and systems. The department also provides oversight of post-market product support (including product events and complaints) and periodic product review.

 
location: Lynnwood, Washington
job type: Permanent
salary: $90,000 - 100,000 per year
work hours: 9 to 5
education: Bachelors
 
responsibilities:

CORE:

•Provide oversight for the review and disposition of Raw Materials, Bulk Drug Substance (API), Drug Product, and Finished Product
•Northpointe Materials/Products: Review/approve documentation including master batch records, specifications, SOPs, and executed batch records, prepare batch files, support testing, change controls, deviations, investigations and CAPA
•Provide GxP oversight of Contract Manufacturing Organizations and business partners involved in the manufacture, testing, and transport of products.
•CMO Fill/Finish Products: GxP oversight of CMOs and the Person in the Plant, review/approve master batch records, specifications, SOPs, change controls, executed batch records, testing, deviations, investigations, CAPA and prepare batch files. Supports teams for technology transfer to CMOs, as needed.
•Facilitate the Periodic Product Review process and prepare the annual product report.
•Supports Metrics Programs like CPV and Manufacturing Data Review in support of product review and reporting.
•Facilitate updates to processes/procedures as it relates to label changes.

Management:

•Establish department and individual goals in alignment with site goals and priorities. Identify performance improvement targets and metrics. Ensure capabilities and capacity is in place to effectively deliver on all departmental commitments and performance targets.
•Anticipate, identify, and communicate risks across the site; while partnering to create strategies and plans to manage risk to the operations. Ensure timely escalation of risks, as required.
•Manage headcount and expenses in area of responsibility to meet approved spending plan while achieving all departmental commitments and project objectives.
•Create functional excellence for area of responsibly and help integrate that capability into daily operational practices.
•Motivate, retain, and develop key employees. Build and sustain employee engagement by creating a culture of execution and an environment within which individuals and teams can excel and continuously improve.
•Remain current on trends and new technologies and developments in areas of responsibility.
•Obtain regular feedback from customers and stakeholders to ensure continual collaboration with cross-functional partnerships.
•Manage execution and support of departments Training Plan.
•Interface with external audit functions as needed to represent the site and Quality function or as potential host representing the site.

Continuous Improvements:

•Work collaboratively with inter-department and cross-functional teams to lead improvement implementations in a timely, effective and compliant manner.
•Identify and prioritize implementation of opportunities to improve Quality processes and practices.
•Ensure Quality management tools/systems and documentation (SOPs, OJTs) are accurate and compliant

 
qualifications:

Bachelor's degree and 10+ years of experience in a quality function in the pharmaceutical/biotech industry and demonstrated management leadership role for 7 years
•Significant experience managing release or CMO quality operations, including disposition.
•Strong inter-personal and professional skills to interact and build relationships with other departments and staff.
•Experience developing and/or mentoring team members and/or individuals.
•Partner Therapeutics offers a competitive compensation/benefits package in a friendly, collaborative culture that values employee engagement and ongoing career development.

 
skills: Quality control, Quality Assurance, MS-EXCEL, MS-Powerpoint, MS-Project, Chemistry, GMP (Good Manufacturing Practice)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.


About the Company

Randstad

Looking for your next great opportunity but not sure where to find it? When you let Randstad US handle your job search, you get the support of one of the world's largest staffing firms partnering with you every step of the way. Our recruiters have the resources to find a job that's right for you. We combine our passion for people with the power of today's latest technologies to find opportunities that fit your skills in environments where you can thrive. Whether you're looking for a temporary or permanent position, our focus is on partnering with you to realize your true potential. And it all starts with your next great role.

Company Size

10,000 employees or more

Industry

Biotechnology/Pharmaceuticals

Website

https://www.randstad.com/