Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
This position is responsible for the promotion of quality awareness and continuous improvement at the site. The Sr. Director Quality is responsible for all quality assurance systems and the implementation of corporate policies and procedures at the specified site(s). He/She will ensure that internal processes and metrics are aligned to create a high level of product quality and consistency. He/She will substantially strengthen quality systems, determining the appropriate infrastructure and resources required to achieve business objectives at the site(s). The Sr. Director Quality is a key member of the Site Leadership Team. This role is responsible for helping to lead teams across the site in an integrated way that supports the delivery of site business goals. He/She will be responsible for a multi-product, multi-host environment and will need to be skilled in the design and execution of segregation and changeover controls between hosts and platforms.
Quality responsibilities within the scope of this job include the following:
• Quality Assurance
• Quality Control
• GxP Compliance
• GxP Training
• Validation QA
• Document Control
Additional responsibilities include:
Provide leadership and strategic direction to the specified quality site(s)
Develop staff to enhance capacity and ensure continuity of the Quality function
Ensure the proper interface of the quality function to product development, manufacturing, engineering/maintenance, and other areas as required
Establish strong relationships with internal and external customers-to build, enhance and ensure quality awareness.
Collaborate with all departments to ensure that quality standards and GxP compliance are met and maintained
Develop and monitor appropriate metrics to track quality and process improvement
Develop the required site processes and competencies to ensure that quality standards are implemented in accordance with corporate goals
I. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Facilitates company's organization for Rockville's quality control, quality assurance and compliance functions
• Ensures compliance with applicable internal and external regulations, standards, policies and procedures, and performance of Rockville's operations
• Develops, implements and monitors progress against the company's strategic quality plan, and related quality objectives
• Ensures that critical or strategic priorities are allocated resources and sufficient quality oversight to ensure timely resolution of issues
• Drives interactions and alignment of quality standards with customers to support compliance and lot release
• Negotiates and assesses customer Quality Agreements
• Maintains effective working relationships with all customers (internal and external) and government agencies by projecting a positive personal and corporate image through appropriate behaviors
• Provides updates and recommendations to the company's executive management with regard to the quality plan and objectives
• Maintains contacts with critical suppliers, professional organizations, consultants and colleagues in order to remain current with industry standards
• Ensures the generation of a comprehensive Validation Master Plan for effective validation and execution of manufacturing processes, test methods, software, cleaning and facilities / equipment / utilities
• Ensure the products are released in a timely manner in compliance with company procedures and regulatory requirements
• Provides organizational and subject matter expert support for company acquisitions of new products, processes or facilities / equipment
• Defines and approves the departmental budget and capital expenditures
• Provides leadership, mentorship and coaching as a member of the site leadership team:
• Directs and coordinates the work efforts of a group of professionals and technicians
• Carries out management accountabilities in accordance with corporate policies and procedures. Management accountabilities include recruitment, training and professional development, planning, assigning and directing work, performance management and measurement and ensuring compliance with employment and safety legislation
• Establishes and maintains structure and organization to ensure efficient achievement of accountabilities and goals and provide flexibility to quickly capitalize on business opportunities
• Acts as the corporate designate for all forms of communication with regulatory authorities on site compliance matters
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
- BS degree in (Biological) Science, Engineering, or Operations Management; Advanced Degree (s) preferred
- Position requires a seasoned Quality Assurance professional with a minimum of 15 years of experience in biopharmaceutical/vaccine companies
- Minimum of 10 years of management/leadership experience
- Ability to effectively negotiate and build collaboration amongst individuals
- Demonstrated ability to develop, coach and mentor key employees
- Experience in a multi-product, multi-host environment and will need to be skilled in the design and execution of segregation and changeover controls between hosts and platforms
- Must have a track record of success and a broad understanding of contemporary quality practices as they apply to product development/clinical manufacturing and commercial operations
- Should have an excellent understanding of Quality requirements in both the US and EU
- Good understanding of protein analytical technologies
- Proven expertise in the design and implementation of quality processes in a world-class medical device/pharmaceutical/vaccine manufacturing organization
- Experience in development of an organizational culture that promotes and sustains quality as an element of superior business performance
- Significant experience and knowledge in Quality areas (Quality Assurance & Quality Control including Validation and proven expertise in the design and implementation of quality processes in a world-class pharmaceutical/vaccine manufacturing organization
- Must have technical knowledge of product design, manufacturing, process design and improvement
- Ability to effectively relate the quality functions to the business as a whole
- Excellent verbal & written communication skills
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.