GxP Supplier Quality Contractor

BCforward
US - Delaware - Delaware City
July 4, 2024

GxP Supplier Quality Contractor

BCForward is looking for GxP Supplier Quality Manager Contractor at South San Francisco, CA 94080
Position Title:GxP Supplier Quality Manager ContractorLocation:South San Francisco, CA 94080Anticipated Start Date: ASAPDuration: 12+ Months Contract to HireJob Type: Full Time/ W2Pay Range: $110/hr on W2Education Level: BachelorsMission of External Quality:
At our core, we are dedicated to ensuring that every patient receives access to high-quality products. Through strategic partnerships, we aim to enhance our internal capabilities, ensuring the timely delivery of top-tier products to patients worldwide.

Main Purpose of the Position:
As a GxP Supplier Quality Manager Contractor, your primary responsibility will be to provide quality expertise and compliance oversight for GMP suppliers, including Contract Development Manufacturing Organizations (CDMOs) and Contract Research Organizations (CROs). You will serve as the Quality Point of Contact for designated GMP suppliers, contributing as a key member of cross-functional management teams to select, implement, and manage these suppliers.

Technical Job Responsibilities:

Oversee all quality activities throughout the lifecycle of GxP suppliers, including due diligence, audit assessments, risk assessments, investigations, and complaints.
Develop, negotiate, and maintain Quality Agreements and Product Specific Requirements with GxP suppliers, ensuring compliance.
Collaborate with suppliers to address gaps in audit responsiveness, CAPA implementation, deviation reporting, complaint management, and change implementation.
Apply cGMP standards as the Quality Point of Contact on product development teams for various platforms.
Manage activities to support the disposition/release of Roche products, ensuring compliance.
Perform product quality risk assessments and develop mitigation plans.
Support or lead supplier improvement initiatives to solve complex manufacturing or quality problems.
Collaborate and manage relationships across GxP supplier management and internal cross-functional teams.

Job Duties/Responsibilities:

Notify Senior Management of potential quality or regulatory issues.
Troubleshoot and drive resolution of quality issues.
Communicate regulatory requirements and Roche expectations to suppliers.
Support internal audits and Health Authority inspections.
Maintain accountability for behaviors described in Roche's Code of Conduct.
Deliver business outcomes in support of departmental objectives.
Flow to work and apply skills where resources are needed.
Complete all job-related training requirements.

Qualifications and Skills:

Bachelor's degree in life sciences.
Minimum of 6 years of experience in the pharmaceutical or biotechnology industry, with CDMO experience desired.
Minimum of 2 years of experience in a GMP Quality Assurance role.
Experience with production of products used in clinical trials.
Sound knowledge of cGMP, ISO standards, and international regulations.
Strong problem-solving skills and critical thinking.
Excellent verbal and written communication skills.
Strong interpersonal, diplomacy, and negotiation skills.
Adaptability to new ways of working and an agile mindset.
Fluency in oral and written English, additional language skills a plus.
Up to 10% domestic and/or international travel may be required.

Benefits:

BCforward offers all eligible employees a comprehensive benefits package including, but not limited to major medical, HSA, dental, vision, employer-provided group life, voluntary life insurance, short-term disability, long-term disability, and 401k.

About BCforward:

Founded in 1998 on the idea that industry leaders needed a professional service, and workforce management expert, to fuel the development and execution of core business and technology strategies, BCforward is a Black-owned firm providing unique solutions supporting value capture and digital product delivery needs for organizations around the world. Headquartered in Indianapolis, IN with an Offshore Development Center in Hyderabad, India, BCforward's 6,000 consultants support more than 225 clients globally.

BCforward champions the power of human potential to help companies transform, accelerate, and scale. Guided by our core values of People-Centric, Optimism, Excellence, Diversity, and Accountability, our professionals have helped our clients achieve their strategic goals for more than 25 years. Our strong culture and clear values have enabled BCforward to become a market leader and best in class place to work.

BCforward 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, or protected veteran status and will not be discriminated against based on disability.

To learn more about how BCforward collects and uses personal information as part of the recruiting process, view our Privacy Notice and CCPA Addendum. As part of the recruitment process, we may ask for you to disclose and provide us with various categories of personal information, including identifiers, professional information, commercial information, education information, and other related information. BCforward will only use this information to complete the recruitment process.

This posting is not an offer of employment. All applicants applying for positions in the United States must be legally authorized to work in the United States. The submission of intentionally false or fraudulent information in response to this posting may render the applicant ineligible for the position. Any subsequent offer of employment will be considered employment at-will regardless of the anticipated assignment duration.

Interested candidates please send resume in Word format to Please reference job code 224104 when responding to this ad.

Read the full job description and apply online on the recuiter's web-site

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