We are currently recruiting for a Director/Senior Director of Quality Assurance in The Woodlands, Texas.
The successful candidate will serve as the head of Lexicon’s quality management function and report directly to the CEO. He/she will be responsible for setting the Company’s health-agency compliance directives and establishing all supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The Director champions the quality leadership for the Company and directs and leads the operations of the department to ensure that goals and objectives are met for product quality and that they are aligned with company goals and in compliance with all applicable regulations.
The incumbent will have the following responsibilities:
• Leads the Company as the quality management executive. Interfaces regularly with the executive management team to ensure ongoing corporate awareness of, and compliance to, regulations. Communicates regulatory risks across the Company. Ensures CEO remains informed on critical compliance issues. Leads Company during health agency inspections. Acts as experienced resource on regulatory compliance issues. Provides reliable solutions to quality management challenges.
• Advises on strategic policy decisions for the Company on critical global quality management directives based on corporate goals, regulatory needs, budget/resources, and long/short term risk issues. Successfully communicates policy and advances a company-wide compliance culture.
• Maintains global quality systems across all Lexicon locations. Designs and deploys company-wide processes for compliance. Reports on metrics measuring ongoing system effectiveness. Ensures systems are sound but flexible to quickly respond to changing regulations and corporate objectives.
• Ensures ongoing Company-wide compliance with all FDA GxP’s, international regulations, and policies/procedures for current pre-market (investigational) through future commercial pharmaceutical products.
• Leads cross-functional teams to execute domestic and international compliance programs supporting clinical, manufacturing, regulatory, legal, information systems, distribution, validation and analytics functions. Participates on development teams to determine quality compliance needs of emerging projects.
• Represents Lexicon’s quality concerns externally by establishing strong communication channels and relationships with consultants, contractors, and medical professionals. Oversees any quality activities outsourced to third-parties.
• Manages staff/resources effectively and creatively. Coordinates workloads with time-critical urgency across all global quality programs.
• Minimum of BS (in Chemistry, Biology or related Life Science)
• Minimum 10+ yrs in regulated pharma GxP drug, biological, and/or device environment with significant experience and a working knowledge in GMP. Experience in GCP and GLP a plus.
• Minimum 10 yrs managing multiple staff levels and successfully management of cross-functional projects teams
• Experience in quality auditing, validation, operations (clinical, manufacturing and/or QC) and regulatory inspections
• Comprehensive knowledge of U.S. and international pharmaceutical regulations including 21 CFR Part 11
• Experience and expertise working in solid dosage forms
• Excellent verbal and written communication skills
• Must be able to communicate effectively between departments/disciplines, and all levels of corporate structure
• Must be able to write sound technical documents to all levels of corporate structure and regulatory authorities
• Must be able to independently organize and lead cross-functional project teams to completion
• Must be capable of setting realistic project timelines and meeting them
• Must be exceptionally attentive to detail and organization
To apply, please visit the careers section of our website: https://lexpharmacareers.silkroad.com/
For additional information about Lexicon and its programs, please visit www.lexpharma.com
Lexicon Pharmaceuticals is an equal opportunity/affirmative action employer.