Senior Quality R&D Lead/Manager (Third Party / External Partners)

Yoh Scientific is actively recruiting for a Senior Quality R&D Lead/Manager (Third Party / External Partners) to work a contract assignment in Collegeville, PA! 

Title: Senior Quality R&D Lead/Manager 
Location: Collegeville, PA
Duration:  One year assignment, possibility of extension
Work Schedule: Full-time, 8a – 5p
Pay Rate: $70.00 - $98.57/hour, based on experience

Overview/Summary
Responsible for designing, developing and implementing Third-Party Quality strategies and quality oversight for external GMP services provide to R&D to ensure that external providers of critical services (CMOs) comply with data integrity and quality standards, GxP regulations and meet national health authority requirements. Promote and implement a Quality and Safety culture within R&D. Provide GMP expertise and regulatory compliance advisory and act as a valuable source to R&D for the selection of GMP suppliers for vaccine R&D projects allocated, while promoting operational efficiency, continuous improvement and contributing to R&D pipeline acceleration.

Responsibilities:

• Assess the current Quality of External Partners to identify any key risks or required Quality Improvement activities.
• Perform Operational Quality oversight of Third Parties, including Deviations, Change Controls, CAPAs and Batch Release Activities for Drug Substance and Drug Product.
• Performance management of project workstream activities.
• Escalate serious cGMP/Regulatory compliance issues following internal procedures.
• Building relationships with cross functional team and stakeholders
• Performance manage quality plans for projects.
• Ensure business continuity in a changing environment, supporting sites internal / external.
• Encourage collaboration across departments to ensure cross-functional input to key decisions and initiatives.
• Identify and manage Quality and Compliance risks that arise from projects.
• Proactively drive a mindset of continuous improvement of processes, value creation and costs savings without compromising compliance, quality or customer service across the team.
• Drive robust RCA and problem solving mindset and use of tools across organization and ensuring CAPAs are implemented to address root causes.

Requirements:

• Must have at minimum a BS degree in life science, or related field
• Must have extensive experience in Third Party (external partners) operation quality oversight including Deviations, Change Controls, CAPAs and Batch Release Activities for Drug Substance and/or Drug Product.
• Demonstrated experience and understanding of GMP
• Demonstrated project management skills
• Risk Management
• Knowledge of applicable manufacturing and packaging processes and technical competence
• Knowledge of PSC network and supply capability
• Problem solving skills
• Excellent communication skills
  

Opportunity is Calling, Apply Now!

What’s In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.

• Medical, Dental & Vision Benefits
• 401K Retirement Saving Plan
• Life & Disability Insurance
• Direct Deposit & weekly ePayroll
• Employee Discount Programs
  

Estimated Min Rate: $70.00
Estimated Max Rate: $98.57

Note: Any pay ranges displayed are estimations.  Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description.  All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.  All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.