Executive Director, Quality & Compliance

Job Title: Executive Director, Quality & Compliance

Department: Quality & Compliance

Reporting To: President, Drug Manufacturing US

Classification: Exempt

Salary Range: 200k-240k/yr, Depending on Experience

What We Do

BioDuro-Sundia is one of the premier Contract Research, Development and Manufacturing Organizations (CRDMO) globally, with more than 2,200 employees.  Our US operations are US headquartered in Irvine, CA. Our 7 global facilities provide integrated solutions and exceptional services to our clientele for challenging preclinical and clinical trial projects. With capabilities spanning Drug Discovery, Development, and Manufacturing, it is no surprise that BioDuro-Sundia is a leading partner of choice.

Why BioDuro-Sundia?

Take the next step in your career and join BioDuro-Sundia today to change lives through the products we help create. Here, you will contribute your talents to meaningful projects that impact the lives of patients around the world and develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Accountability, Respect, Tenacity, Results and Integrity are embedded in everything we do. No matter what your role may be, BioDuro-Sundia strives to ensure all our employees are empowered and given the necessary tools to lead us in our relentless pursuit of success.

Job Overview/Summary

The Executive Director, Quality & Compliance (ED) will establish and maintain a compliance program consistent with applicable regulatory requirements, standards, and established company policies and procedures. In addition, this role is intended to provide leadership and technical oversight to all functional quality control areas as well as contract services and CMOs that provide QC functions.

The ED is responsible for management of internal and external audits, regulatory inspections and related compliance activities. They will manage the associated assessment and remediation activities as a result of internal and external audits.

The ED shall establish and maintain programs to ensure the verification and monitoring of the effectiveness of the Quality System and its compliance to applicable regulations and standards and ensure relevant metrics are escalated as needed and/or routinely communicated to senior leadership through the Management Review process. They will establish Quality Objectives ensuring an effective monitoring and escalation process along with establishing programs to effectively monitor and assess the Quality System through representative metrics.  The ED shall assess the performance of the Quality System and ensure continuous improvement of such programs.

The ED shall support all activities where product is developed, manufactured, tested, dispositioned, and distributed. Further, they will proactively monitor the external environment to identify new or emerging regulations, determine the impact and create implementation strategies in alignment with BioDuro’s business goals.

Quality Systems: establish programs, guidelines, and procedures related to areas of responsibility to include but not limited to:

·         Management Review

·         CAPA

·         Non-Conformances

·         Quality Systems Review, Quality Objectives

·         Quality Metrics

·         Change Control Management

·         Data and Document Management

·         Records Management

·         Computer Systems Validation

·         Training Management

The ED, Quality and Compliance will establish and oversee the Quality Systems improvement strategy that includes responsibilities for development, implementation and the continuous improvement of the Quality System. They will partner with cross functional leaders across the company to drive standardization of the Quality Systems and compliance with established Policies and Procedures.

They are responsible for the development of Quality personnel in terms of leadership, training, and expansion of responsibilities.

Essential Functions and Responsibilities

• Manage all aspects of BioDuro’s Product Quality (Quality Systems, Quality Assurance, & Quality Control)
• Ensure the Total Quality Management system which includes establishment of high standards, as well as identification of and prioritizing improvement projects.
• Focus on standardization of methodologies across the company
• Provide direct and functional direction on policies from a quality perspective with client focus.
• Troubleshoot critical issues using quality tools to resolve root cause and corrective actions.
• Direct root cause investigations/corrective actions and provide a quality face to Clients, as appropriate.
• Develop strong liaisons cross-functionally to ensure organizational alignment and focus on quality across all areas of the company
• Develop talent and provide overall training and guidance to the organization that deepens quality culture and progresses BioDuro towards being a world class quality organization
• Key member of Operations Steering Team primarily focused on risk reduction opportunities, particularly as they relate to Quality
• Responsible for the performance management of Quality Systems in a multi-site operation through guidance and direction to site Quality teams.
• Formulate and manage the development and implementation of goals, objectives, policies, procedures, flow charts, forms and systems pertaining to the QMS.
• Represent Quality within the corporate management team and report quality metrics, issues, and trends.
• Troubleshoot and collaborate with the Executive team and other dept. heads to ensure the company’s quality priorities and objectives are aligned with the overall company direction and to advance the goals of the business.
• Monitor and analyze trends in company KPI's and identify opportunities for strategic improvement.
• Act as escalation route for all Client concerns and build Client relationships to improve the performance and reputation of the business.
• Confer with business development to define Client requirements and expectations, ensuring Client and regulatory requirements are met at all times.
• Interact with Clients to identify opportunities to improve quality and establish feedback with manufacturing and development personnel.
• Ensure that products and services meet Client needs and expectations while fulfilling corporate quality objectives.
• Meet with suppliers, Clients, quality representatives, regulatory agencies, and company personnel to discuss and resolve quality problems.
• As necessary, implement corrective and preventative action plans and monitor their effectiveness.
• Participate in internal and external quality audits and regulatory inspections.
• Cooperates with other top management personnel in formulating and establishing company policies, operating procedures, and goals.
• Ensure that BioDuro maintains all industry standard licenses.
• Conducts management meetings with product assurance program department heads to establish, delineate, and review program organizational policies, to coordinate functions and operations between departments, and to establish responsibilities and procedures for attaining objectives.
• Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures.
• Reviews technical publications, articles, and abstracts to stay abreast of technical developments in industry.
• Provide support to drive a continuous improvement philosophy focused on improved compliance, right-first-time and process efficiency while creating an environment of open communication, participation and information-sharing within and between teams within Quality and throughout facility.
• Provide support in guiding the strategic growth of the Quality operations including capacity planning, capital acquisition, and integration of new capabilities.
• Recommend approaches for scientific and quality strategies to facilitate overall project and process success: set specifications for test, monitor process, product utility and environmental controls.
• Development and performance management of direct reports including: training, coaching and mentoring goal setting, performance evaluation and feedback, approves performance reviews for group members.
• Build a team environment based on collaboration, Client service, scientific excellence and process effectiveness within the Quality groups.
• Lead through mentorship and management of the Quality teams, including but not limited to, the assignment of projects and establishment of project priorities and management of resources within Quality; provide group leadership with coaching and mentoring guidance related to hiring, learning and development, performance management and problem resolution.
• Promote and follow all regulatory guidelines, GMP guidelines, Environmental Health and Safety regulations as required by the job function.

·         This job description is subject to change at any time.

Requirements

• Minimum 15+ years of well-rounded Quality and Regulatory Compliance experience (Operations Quality a plus) in positions of increasing responsibility, with a preferred focus CMC.
• Minimum 7+ years in a leadership capacity
• Proven, recent corporate leadership experience within a pharmaceutical or CMO company
• Clear ability to work effectively with relevant stake-holders cross-functionally to influence and impact operations. Highly collaborative and able to work through influence and negotiations creating win-win outcomes.
• Demonstrated success navigating complex business environments and driving efficient and effective execution of programs.
• Proven experience shoring up quality management systems and comprehensive audit programs.
• Experience working directly with the FDA, Health Authorities and other governmental agencies on Regulatory Compliance matters.
• Exceptional leadership skills with deep business acumen; proven ability to inspire, motivate and provide professional development to Quality professionals
• Ability to inspire and build effective relationships with C-suite, peers, and ability to attract and retain a team by leading with inclusion and diversity that will motivate people to produce their best work.
• Considerable experience and comfort with building rational strategies and defending your ideas with evidence to influence key decision makers.
• Strong data-driven leader with deep expertise in reporting, project management, performance analysis, and prioritization skills.
• Demonstrated success leading the change management efforts required when introducing new processes and evolving the capabilities of an organization.
• Ability to organize logical arguments into well written final documents.
• Strong verbal and written communication skills, proven ability to translate technical documentation into effective compliance documents

Preferred Qualifications 

• RAC certification, ASQ - CQA, CQE or SCQE, and/or ISO Lead Assessor is desirable

Benefits

Position Benefits

We offer full health benefits, paid vacation and sick leave, an aggressive bonus structure, and market-competitive salaries to all our employees. In addition, BioDuro-Sundia provides employees with a variety of engaging employee and community outreach events. We strive to reward and promote employees who exhibit our values of Accountability, Respect, Tenacity, Results and Integrity.

EOE and Accommodation

We value diversity and are proud to be an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. BioDuro-Sundia provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans. If you need accommodation in connection with the recruiting process due to a disability, you may use the alternative methods by emailing humanresources@BioDuro-Sundia.com. If you are selected to interview for a position, you may also request accommodation with our team directly.

Notice to Agency and Search Firm Representatives

BioDuro-Sundia is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any BioDuro-Sundia employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of BioDuro-Sundia. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.