Executive Director, CMC Development QA (Onsite San Diego)

Regulatory/QA Group               ·                US CA San Diego (On site)            ·           Full-time

Remote type: On-Site
Locations: US CA San Diego
Time type: Full time
Posted on: August 18, 2023
Job Requisition ID: R3938

Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose – to relieve suffering for people with great needs, but few options.

What We Do:

Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine and psychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson’s disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. *in collaboration with AbbVie

About the Role:

Responsible and accountable for establishing strategy, policies, and procedures for CMC related GLP/GMP activities 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. Oversight of 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. Coordinates interdepartmental activities both internally and externally to ensure suppliers, vendors, and internal functions meet quality standards for GLP/GMP related tasks and functions. Lead and guide investigations and resolve potential product quality 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. Act as deputy to the department and assist in all areas as necessary to ensure quality at the company.

Your Contributions (include, but are not limited to):

• Oversees quality compliance of internal and external drug substance and drug product manufacturing, laboratory operations, and/or contract research organizations
• Responsibilities may include the review and release of product, GLP/GMP auditing, training, creation of standard operating procedures (SOPs) and document control
• Responsible and accountable for batch release for both developmental and commercial products made at or for the company
• Oversees CMC related vendor qualification and compliance audits. Evaluates site audit findings and responds to these findings with process and procedure improvements that drive quality efficiency and effectiveness
• 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
• Oversight and management of Regulatory inspections internally and externally. Direct participation in internal Regulatory inspections
• 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
• Develop solutions and drive risk analysis and mitigation strategies
• Facilitates, reviews and approves quality investigations such as complaints, deviations, out of trend, and out of specifications results. Ensures that investigations utilize a risk-based approach and conclusion
• Ensures in-process and finished products conform to in-house policies and procedures as well as other applicable regulations and guidelines. Reviews, trends, and analyzes data
• Ensure that exceptions are analyzed for corrective preventive actions and product impacts
• Provide technical expertise for product quality decisions
• Oversee development, maintenance and management of quality systems
• Provide leadership, guidance and direction to staff. Delegate and motivate personnel to achieve goal
• Other duties as assigned

Requirements:

• BS/BA in Chemistry, Biology, or related life-science field and 17+ years (preferred 20+ years experience) broad experience within the pharmaceutical or biotechnology industry, with international Quality Assurance experience. Demonstrated regulatory audit experience both internally and externally to the firm. Previous experience within a quality assurance lab environment and in a supervisory role. Management experience for both development and commercial quality assurance teams OR
• Master’s degree in Chemistry, Biology, or related life-science field and 15+ years (preferred 20+ years of experience) of similar experience noted above and Extensive previous strategic leadership experiences also required
• 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
• Broad pharmaceutical industry experience with a working knowledge of quality systems and regulatory compliance requirements within a development and commercial drug manufacturing environment
• Solid knowledge of all regulations pertaining to GxP’s and current industry trends as related to pharmaceutical, biological and gene therapy products
• Knowledge and expertise in one or more GLP, GCP and GMP systems throughout the product lifecycle
• Expert at managing complex and multiple work streams in changing circumstances
• Acts as a “trusted advisor” across the company and may be recognized as an external expert
• Provides strategy, vision and direction regarding issues that may have company-wide impact
• Requires in-depth knowledge of the functional area, business strategies, and the company’s goals
• Possesses industry-leading knowledge
• Exceptionally strong team leader and team player with excellent interpersonal and communication skills, and experience working with end-users in a coaching capacity
• Experience developing and managing departmental operating and budgets
• 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
• 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
• Ability to integrate and apply feedback in a professional manner
• Holds self and others accountable for adherence to high work and ethical standards
• Travel + or – 25%

#LI-LS1

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.

The annual base salary we reasonably expect to pay is $203,800.00-$303,250.00. 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.

Please click here to apply.