Associate Director QA Supplier Qualification & Auditing

At Roche Innovation Center Philadelphia (Pharma Technical Cell and Gene Therapies), we build on Roche's 125-year history as one of the world's largest biotech companies, globally recognized for providing transformative innovative solutions across major disease areas. We combine human capabilities with cutting-edge technological innovations to do what our patients need next. Our commitment to our patients' needs motivates us to deliver gene therapies that evolve the practice of medicine.

The Opportunity:

• You manage the supplier and service provider qualification and auditing program.  

• You drive excellence by partnering cross-functionally across the organization to support new material introduction for clinical programs and managing supplier change notifications.

• You work in a dynamic, fast paced environment with shifting priorities. This includes interacting with Senior Management, peers and colleagues throughout the organization as well as external domestic and international suppliers and partners

• You utilize your strong analysis and problem-solving skills to ensure conformance with domestic and international CGMPs while maintaining a collaborative environment.

• You work collaboratively in the process of conflict resolution to address audit observations, resolve deviations, generate effective CAPAs, and identify requirements to implement changes in a controlled GMP environment.

Who You Are:

• You possess a Bachelor’s Degree in Chemistry, Biology or a related scientific discipline, or equivalent work experience; Graduate degree is a plus

• You have 12-15+ years’ experience in the biotech/biopharma/pharma industry with pharmaceutical products intended for human use

• You have experience with Regulatory Inspections

• You are knowledgeable and capable in the following areas: ​

  • cGMP and FDA/EMA/ROW biologics & drugs, cellular and human gene therapy regulations

  • Aseptic/Sterile Processing regulations and guidelines

  • Facilities, Equipment, Process and Analytical validation, Supplier Qualification & Auditing

  • Auditing of: CMOs, CTLs, Warehouses, Labeling & Packaging facilities, Distribution Centers, Suppliers of Raw Materials & Components, Software vendors

• You have proven ability to review investigations, develop effective corrective and preventive actions.

• You have broad  knowledge of Quality System implementation, validation and maintenance including but not limited to supplier qualification, auditing, batch records review and lot release, non-conformance management, deviation investigations, effective CAPA programs, and change control programs

• Knowledge and experience with Risk-based approach to Quality System implementation.

• Excellent writing skills

Preferred Experience:

• 5-8+ years of Management/Supervisory experience 

• Production of human cell/gene therapy products experience

• Experience working with products registered globally

Location

You are local to Philadelphia. Relocation benefits are not approved for this posting. This is an onsite role; no remote opportunities are available at this time.

This position requires a moderate amount of travel (less than 5%), and may require occasional weekend work, off hours and holidays as needed.

The expected salary range for this position based on the primary location of Philadelphia is $126,000 -- $234,000.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors determined by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed in this link.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or l