Associate Director, QA Operations (Small Molecule) (Remote)

Location
Working from Home
Posted
Jun 03, 2022
Ref
4502806004
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

ASSOCIATE DIRECTOR, QA OPERATIONS (Small Molecule) (Remote)

Position Summary:

This leadership position is responsible for providing quality oversight of GBT small molecule products throughout their CMC lifecycle. Develop, approve, monitor, and maintain critical quality standards to proactively minimize product quality risks. Ensures quality management of products and processes, leading improvement, and alignment with current regulatory expectations. The successful candidate must have experience in quality management of clinical and commercial product, a strong knowledge of root cause analysis and a clear understanding of cGMP operational quality systems.

GBT places a high value on cooperative team dynamics and a positive, “can-do” work ethic.  The ideal candidate thrives in a fast-paced environment where a strong sense of urgency is the norm and exceptional communication, and interpersonal skills are needed.

Essential Duties and Responsibilities:

  • Provide quality oversight and strategic guidance throughout the CMC lifecycle management of GBT’s products
  • Manages batch disposition for the US market of API, bulk drug product, and packaged/ labeled drug product
  • Manage approval of supporting manufacturing records, including associated change controls, investigations (deviations, out-of-specification/out-of-trend), and analytical data
  • Quality Lead on all Major investigation, critiquing root cause analysis and associated CAPAs. Review and approve contract manufacturing organization (CMO) investigations (deviations, out-of-specification/out-of-trend, complaints)
  • Support GBT Global (QPs & RPs) in disposition of GBT product for the EU and Rest of the World (ROW) Markets
  • Recognizes key product quality risks and ensures timely escalation of the identified risks to the appropriate levels of the organization
  • Provides guidance and Quality input to the critical quality attributes (CQAs) for release and stability specifications
  • Supports site and analytical method transfers
  • Key contributor to the Annual Product Quality Review (APQR)
  • Manages approval of test methods, method validation protocols and reports, stability protocols and reports
  • Supports/manages approval of quality agreements, SOPs, and specifications (raw materials, regulatory starting materials, in-process, intermediates, finished product, stability)
  • Manages approval of manufacturing process validation protocols and reports
  • Establish and maintain phase-appropriate procedures and processes related to QA Operations, that will effectively support GBT products throughout the CMC lifecycle of GBT’s products
  • Employ the principles of ICH Q8 (Pharmaceutical Development) and Q9 (Risk Management) to support product lifecycle management
  • Serve as a Quality Subject Matter Expert (SME) to support departmental functions and build partnerships and collaborate with stakeholders in other areas of the business to ensure success of the quality operations
  • Must be able to maintain a “big picture” perspective without losing site of the details necessary to meet deliverables and deadlines
  • Support the organization in maintaining a work environment focused on quality and one that fosters learning, respect, open communication, collaboration, integration, and teamwork
  • Interpret Regulatory Authority regulations, guidelines and policies
  • Communicate and ensure compliance with Quality objectives, policies and procedures

Qualifications:

  • A BS, MS, or PhD in a scientific related field
  • Minimum 7 years of experience
  • Experience with batch disposition and review of analytical-related documents (test method and stability protocols and reports)
  • Ability to make decisions based on phase specific GMP requirements, and appropriate risk assessment
  • Experience in management and leadership of complex product investigations, root cause analysis and associated CAPAs
  • In-depth knowledge and experience implementing phase appropriate procedures and processes related to QA Operations
  • In-depth knowledge of ICH guidelines related to stability (Q1A-Q1F), Analytical Validation (Q2), and Specifications (Q6A-Q6B)
  • Experience with interacting with QPs, RPs and domestic/international CMOs and CROs
  • Strong and clear understanding of cGMPs and pharmaceutical industry best quality practices
  • Demonstrated leadership in cross-functional and culturally diverse team settings
  • Excellent interpersonal skills with the ability to influence individual and teams across the organization in the absence of a direct reporting relationship
  • Able to work collaboratively in a matrix structure while ensuring that timelines and deliverables are met
  • High energy, enthusiasm and excellent leadership and management skills
  • Excellent verbal, written, interpersonal, organizational, and communication skills are necessary

Fit with GBT culture:

  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity

NOTE:  This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company’s facilities.  The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.