Director, Qa Jobs

Establishes strategy, policies, and procedures at all levels so quality improvement efforts will meet internal and external customers' needs and expectations.
Oversees a technical team of highly trained and skilled quality managers and quality specialists in order to implement the quality systems and activities.
Oversees the quality management systems in accordance with federal, state and international regulations and standards to ensure the continuing suitability, adequacy, and effectiveness, including assessments of opportunities for improvement and need for change.
Provides professional development opportunities, ensuring technical acumen is commensurate with innovative CMC platforms and emerging technologies.
Coordinates interdepartmental activities both internally and externally to ensure suppliers, vendors, and internal functions meet quality standards.
Lead and guide investigations and resolve potential product quality issues and/or quality clinical issues to improve efficiency.
Selects, develops and evaluates personnel to ensure the efficient operation of the function. Ensures budget, schedules, and department performance requirements are met. Ensure compliance with the company's quality management system and ensure that all individuals reporting to him/her comply with the company's quality management system.

• Oversight and management of Regulatory inspections internally and externally. Direct participation in internal Regulatory inspections
• Oversees quality compliance of internal and external drug manufacturing and laboratory operations and/or contract research organizations
• Trains staff concerning compliance, SOP’s and the development process for new drugs
• General
  • Oversees quality compliance of internal and external drug manufacturing and laboratory operations and/or contract research organizations
  • Responsibilities may include auditing, training, creation of standard operating procedures (SOPs) and document control
  • Collaborates and participates in product development teams and/or clinical development teams
  • Oversight and management of Regulatory inspections internally and externally. Direct participation in internal Regulatory inspections
  • Provides input and supporting documentation for Regulatory Documentation including IND’s CTA’s and NDA’s
  • Negotiates and maintains agreements and contracts as they relate to quality assurance
  • Trains staff concerning compliance, SOP’s and the development process for new drugs
  • Selects, develops, provides guidance to and evaluates QA personnel to ensure the efficient operation of the function
• Selects, develops, provides guidance to and evaluates QA personnel to ensure the efficient operation of the function
• Collaborates and participates in product development teams and/or clinical development teams
• Provides input and supporting documentation for Regulatory Documentation including IND’s CTA’s and NDA’s
• Negotiates and maintains agreements and contracts as they relate to quality assurance
• Responsibilities may include auditing, training, creation of standard operating procedures (SOPs) and document control

• Other duties as assigned related to GCP compliance and monitoring
• Responsibilities include internal and external quality oversight and auditing of GCP activities and facilities
• Responsibilities may include review and approval of clinical protocols, brochures, both clinical and pre-clinical final reports, annual updates and publications, for compliance with GMP, GLP, GCPs for both development and commercial products
• Responsibilities may include quality oversight and auditing of GLP activities and facilities
• GCP (when assigned)
  • Responsibilities may include quality oversight and auditing of GLP activities and facilities
  • Responsibilities include internal and external quality oversight and auditing of GCP activities and facilities
  • Responsibilities may include review and approval of clinical protocols, brochures, both clinical and pre-clinical final reports, annual updates and publications, for compliance with GMP, GLP, GCPs for both development and commercial products
  • Other duties as assigned related to GCP compliance and monitoring

• Responsibilities may include review and release of product for development or commercial products made at or for the company
• Interacts directly with CMC technical experts and senior leadership
• Ensures that exceptions are analyzed for corrective actions and product impacts
• Represents Sr. QA leadership in CMC strategy and ad hoc meetings
• GMP (when assigned)
  • Responsibilities may include review and release of product for development or commercial products made at or for the company
  • Develops strategy and procedures that ensures phase appropriate requirements in dynamic CMC activities
  • Quality oversight of contract manufacturing facilities and leads CMC related vendor qualification and compliance audits. Evaluates site audit findings and performance. Responds to these findings with process and procedure improvements that drive quality efficiency and effectiveness
  • Facilitates, reviews and approves quality investigations such as complaints, deviations, out of trend, and out of specification results. Ensures that investigations utilize a risk-based approach and conclusion
  • Ensures that exceptions are analyzed for corrective actions and product impacts
  • Interacts directly with CMC technical experts and senior leadership
  • Provides expertise to QA CMC team and matrixed clinical teams
  • Represents Sr. QA leadership in CMC strategy and ad hoc meetings
• Quality oversight of contract manufacturing facilities and leads CMC related vendor qualification and compliance audits. Evaluates site audit findings and performance. Responds to these findings with process and procedure improvements that drive quality efficiency and effectiveness
• Provides expertise to QA CMC team and matrixed clinical teams
• Develops strategy and procedures that ensures phase appropriate requirements in dynamic CMC activities
• Facilitates, reviews and approves quality investigations such as complaints, deviations, out of trend, and out of specification results. Ensures that investigations utilize a risk-based approach and conclusion

• Manages relationships with QA service providers, including but not limited to consultant auditors, quality consultants, etc
• Establishes and/or leads vendor QA-QA relationships with preferred vendors, including implementation of quality agreements, as applicable
• Maintain Inspection readiness by monitoring vendor compliance profiles and regulatory inspection trends
• Quality Operations (when assigned)
  • Provide quality and compliance support for Product Complaints, Vendor Qualification/Audits management and GMP analytical Lab
  • Develops, implements, and manages a GMP vendor management system
  • Maintains a comprehensive risk based GMP compliant vendor management and quality audit program
  • Manages relationships with QA service providers, including but not limited to consultant auditors, quality consultants, etc
  • Establishes and/or leads vendor QA-QA relationships with preferred vendors, including implementation of quality agreements, as applicable
  • Manages the Internal Audit Program for the GMP Operations
  • Maintain Inspection readiness by monitoring vendor compliance profiles and regulatory inspection trends
• Manages the Internal Audit Program for the GMP Operations
• Provide quality and compliance support for Product Complaints, Vendor Qualification/Audits management and GMP analytical Lab
• Maintains a comprehensive risk based GMP compliant vendor management and quality audit program
• Develops, implements, and manages a GMP vendor management system

• Other duties as assigned

• Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively
• Proven ability to cultivate and develop relationships with cross functional teams and vendors
• BS/BA degree in a life science or related field and 15+ years of broad pharmaceutical industry experience including quality systems and regulatory compliance requirements within a development and commercial drug manufacturing environment, one or more GLP, GCP and GMP systems throughout the product lifecycle, developing SOP's and leading GXP audits and inspections or related experience required OR
• Broad pharmaceutical industry experience with a working knowledge of quality systems and regulatory compliance requirements within a development and commercial drug manufacturing environment
• Supervisory experience in either development or commercial quality assurance teams
• Ability to solve problems and troubleshoot issues
• Holds self and others accountable for adherence to high work and ethical standards
• Master's degree in a life science or related field and 13+ years of experience as noted above and Previous managerial experience also required
• Excellent relationship building and persuasion skills with the ability to motivate and influence others; demonstrated a record of overcoming resistance to change, and driving the adoption of new processes from a position of indirect or informal authority
• Exceptionally strong team leader and team player with excellent interpersonal and communication skills, and experience working with end-users in a coaching capacity
• Demonstrated leadership ability to identify, manage and develop QA teams
• Knowledge and expertise in one or more GLP, GCP and GMP systems throughout the product lifecycle
• Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization
• Solid knowledge of all regulations pertaining to GxP’s and current industry trends as related to pharmaceutical, biological and gene therapy products
• Ability to integrate and apply feedback in a professional manner
• Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact
• Expert at managing complex and multiple work streams in changing circumstances
• Demonstrated analytical ability, strong leadership skills, exceptional communication skills, creativity, and the ability to effectively manage and implement multiple projects
• Demonstrated experience with leading cross-functional teams through development, implementation, application, and maintenance of Quality Systems which comply with FDA QSR, GMP, and the related US and international regulations and standards
• Self-motivated, hands-on critical thinker and problem solver, with the ability to lead by example, with an enthusiastic, optimistic outlook, and a collaborative style
• Expertise developing and managing departmental operating and budgets

The annual base salary we reasonably expect to pay is $169,300.00-$270,900.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.