GxP Supplier Quality Manager Contractor

BCforward is looking for GxP Supplier Quality Manager Contractor

Job Title: GxP Supplier Quality Manager Contractor

Location: South San Francisco, CA, USA, 94080

Expected Duration: 12 months with the possibility of extension.

Pay rate: 110$/hr.

Expected Start Date: 7/1/2024

Position Description

Mission of External Quality

We serve our patients through external partnerships because access to quality products is every patients right.

We leverage external partners in order to offer flexibility to our internal capacity at the right cost, speed and quality

We enable our external partners to reliably deliver compliant, quality products to our supply chain customers, so that we can deliver to patients worldwide.

We do this through cross-functional collaborations ensuring quality process excellence and continuous improvement.

Main Purpose of the Position

Provide quality expertise and compliance oversight for GMP suppliers such as Contract Development Manufacturing Organizations (CDMOs) and Contract Research Organizations (CROs) for the delivery of Roche products including bulk drug substance, bulk drug product and finished goods

Serve as the Quality Point of Contact for designated GMP suppliers and Roche products. Contribute as a key member of GMP supplier cross-functional management teams to select, implement and manage these suppliers.

The ideal candidate has expertise in and experience with clinical GMP Drug Substance and/or Drug Product production.

Technical Job Responsibilities

Oversee all required quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage, and Decommission), such as due diligence and/or Roche audit assessments, risk assessments, complex investigations, and complaints.

Develop, negotiate and maintain Quality Agreements and Product Specific Requirements with GxP suppliers, and ensure compliance with agreements.

Collaborate with GMP suppliers to address any gaps in audit responsiveness, CAPA implementation, deviation reporting and management, complaint management, investigation closure, and change implementation with regard to quality and timeliness with the supplier; and escalate as appropriate.

Apply phase appropriate cGMP as the Quality Point of Contact on product development teams for a variety of platforms, such as large molecule, small molecule, conjugates, and oligonucleotides.

Manage applicable activities to support disposition/release of Roche products including approval of master process and testing documentation, batch record review, resolution of investigations, assessment of changes, and ensuring cGMP compliance.

Perform product quality risk assessments, develop mitigation plans and monitor implementation as applicable.

Support or lead supplier improvement initiatives to solve complex manufacturing or quality problems. Identify, design and implement process and system improvements.

Job Duties/Responsibilities

• Collaborate and manage relationships across GxP supplier management and internal cross-functional teams to ensure quality expectations are aligned with Roche objectives.
• Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance.
• Troubleshoot and drive the resolution of quality issues, fostering effective interdepartmental and cross-functional partnerships.
• Communicate new and updated regulatory requirements and applicable Roche expectations to GxP suppliers as applicable, and evaluate systems in place.
• Support internal cGMP audits and Health Authority inspections as needed, and follow up on any corrective measures.
• Sign documents as authorized and described by Roche policies, procedures and job descriptions.
• Be accountable for behaviors described in Roches Code of Conduct.
• Deliver business outcomes in support of departmental objectives. Maintain and communicate work priorities to meet goals and timelines.
• As part of an agile organization, flow to work and apply skills where resources are needed
• Complete all job-related training requirements prior to performing GMP-job functions and strive to continuously improve on knowledge and skills in quality, compliance and technology.
• Identify, support and/or lead continuous improvement initiatives that benefit External Quality and other organizations.

Qualifications and Skills

• B.A. or B.S. degree in life sciences
• Minimum of 6 years total experience in the pharmaceutical or biotechnology industry. Experience with CDMO desired.
• Minimum of 2 years' 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 for pharmaceuticals. Ability to interpret quality standards as they relate to GxP suppliers, including application of phase appropriate cGMP during product development for a variety of platforms, such as large molecule, small molecule, conjugates, and oligonucleotides.
• Demonstrated ability to apply cGMP concepts and requirements to evaluate batch disposition using sound judgment and decision making. Strong problem solving skills using critical thinking, identifying risk based resolutions
• Excellent verbal and written communication skills
• Strong interpersonal skills, diplomacy, and negotiation skills to influence and accomplish business objectives
• Excellent influencing and negotiating skills when interacting with stakeholders at all levels within Roche worldwide operations, CDMOs and CROs.
• Adaptability to new ways of working, and an agile and innovation mindset.
• Ability to work in a purpose driven organization, taking full ownership for assigned roles and tasks, continuously willing to improve individual and team effectiveness.
• Fluency in oral and written English is a must. Additional language skills are a plus.
• This position may require up to 10% domestic and/or international travel

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 Please reference job code 223458 when responding to this ad.