Associate Director, Quality Compliance - Vendor Management (GCP/BIMO)

General Scope and Summary

SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role as an Associate Director, Quality Compliance - Vendor Management. In this position, you will interface and build strong partnerships with other teams within SAGE, to ensure appropriate Quality oversight of Contract Service Providers throughout the lifecycle of our development programs.

Roles and Responsibilities

• Manage vendor qualification efforts across SAGE, working closely with subject matter experts in GCP, GVP, and GLP areas. Support GMP and GDP vendor qualifications as needed.

• Partner with business process stakeholders to evaluate vendors using a risk-based and phase appropriate model across all GxP areas impacting Bioresearch Monitoring (BIMO) compliance.

• Advise transversal non-GxP functions on vendor selection criteria and related considerations for selecting Contract Service Providers to collaborate with.

• Schedule third party GxP vendors for initial qualification or requalification based on criticality, compliance history, as well as future business plans.

• Oversee the conduct of Vendor Audits and Mock Inspection preparation activities as per the approved schedule. Supervise consultant auditors and conduct audits as applicable.

• Manage the review and negotiation of Quality Agreements on behalf of SAGE.

• Drive Risk Mitigation and Continuous Improvement initiatives by partnering with functional stakeholders to reduce risk in an iterative fashion.

• Leverage risk mitigating actions to drive cultural enabling change.

• Support the management of regulatory inspections, both as a support team leader and a Subject Matter Expert, during on-site and virtual/remote evaluations.

• Train new auditors on investigation techniques, technical aspects, and relationship management.

• Enhance policies and procedures and ensure compliance with applicable regulations.

• Collaborate across functions and within Quality to identify areas of improvement and implement enhancements.

• Ensure correct resource allocation of internal and external Vendor Management resources to projects and continuous improvement initiatives.

• Create and drive improvement in key performance metrics reportable to Quality management.

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have excellent interpersonal skills, the ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, and the ability to identify issues and raise to key stakeholders to develop relevant and realistic plans, programs, and recommendations. Must have a demonstrated ability to translate strategy into action, excellent analytical skills, and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.

Basic Qualifications

• Bachelors degree.

• 6+ years of related Quality Assurance or Compliance experience in the pharmaceutical or biopharmaceutical industry.

Preferred Qualifications

• Ability to travel to Sage corporate offices and third-party vendor locations, up to 25%.

• Advanced degree with 10+ years of experience in a Quality Compliance related role.

• Extensive experience leading internal or vendor audits across several GxP areas.

• Strong working knowledge of GXP regulations and industry best practices related to Bioresearch Monitoring (BIMO), including GCP, GLP, and GVP areas. Prior experience working within a REMS program desirable.

• Experience with all phases of the Product Lifecycle (early stage clinical through commercial).

• Familiarity with Good Manufacturing Practices and related regulations, including 21 CFR Part 211 and ICHQ7.

• Knowledge of 21 CFR Part 11 and EU Annex 11 regulations, data integrity, and GAMP5 concepts, applications, and best practices.

• Certification as a Qualified Auditor by an established industry organization.

• Experience supporting regulatory inspections and audits.

• Demonstrated ability to apply risk-based approaches to achieve a phase appropriate and fit-for-purpose outcome.

• Past accomplishments of implementing cross-functional continuous improvement (Six Sigma Belt certification preferred).

• Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.

• Must possess excellent communication and presentation skills, relationship-building capabilities, and a proven ability to influence decision-making without authority.

• Strong team player that has a customer service approach and is solution-oriented.

• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.

• Embrace our core values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.

• Excitement about the vision and mission of Sage.

• The actual salary offered within the range is dependent on a variety of factors including, but not limited to, relevant experience, qualifications, education, skills, and performance.
• This position is eligible to participate in the Companys annual bonus plan; the bonus varies based on performance and is subject to the standard terms and conditions of the incentive program.
• To support your well-being, we offer a comprehensive benefits and wellness package, which includes medical, dental, and vision coverage upon hire. More information can be found in our Benefits Guide.