Sr. Director, Packaging and Labeling Operational Quality
Boston, MA, United States
Sr. Director, Packaging and Labeling Operational Quality page is loaded Sr. Director, Packaging and Labeling Operational Quality Apply locations Boston, MA time type Full time posted on Posted 26 Days Ago job requisition id REQ-19619 Job Description
General Summary:
The Sr. Director of Packaging and Labelling Operational Quality will advance compliance oversight for packaging and labelling validation, commercial supply, and product launches in North America and worldwide across the Small Molecule portfolio. The Sr. Director will have a broad role working with stakeholders across Manufacturing, Supply Chain and Regulatory. The role will support International global expansion product launches and assessment of product requirements including labelling requirements in local countries/affiliates.
The Sr. Director is responsible for oversight of department activities, technical development of personnel and ensuring the quality of deliverables within the role's purview. The incumbent is known for significant technical expertise and establishes the strategic alignment of group and department goals with its projects and activities, refining and adapting as necessary through proactive monitoring/measurement.
The Sr. Director will foster strong collaboration and partnership from the team with external and internal stakeholders, and the International Quality leadership team. The individual will partner with CDMOs ensuring quality operations and advancing improvements as necessary.
Key Duties and Responsibilities:
Establish robust Quality Processes/Process Ownership for the packaging and labelling validation and re-supply as well as commercial product launches and late phase customization processes
Develop project plans for all projected product launches and manage cross functional discussions and label requirements for each region
Participate in Geographic Expansion activities and product launch risk assessments to ensure that Quality related actions are planned into projects and completed in line with the commitments
Provide leadership and partner with QA management in proactive and strategic planning for QA and translation of the strategy to operating plans for execution
Partner with stakeholders across enabling functions for alignment of strategies, and optimization of programs for delivery, specifically with respect business deliverables vs. QA-specific initiatives
Establish and direct development of Quality Metrics to support process improvement activities
Develop plan and lead Quality team to enable support for future small molecule portfolio advancement
Develop team to for individual and function growth
Build highly functional relationships with CDMO Quality leadership to influence compliance performance and ensure Quality Agreement expectations
Business travel can be up to 30% of time
Knowledge and Skills:
Excellent communication skills and a proven track record influencing/building/promoting a culture of Quality and Excellence
Proven ability to design/evolve and /or implement quality strategies and operational planning and oversight in a fit-for-purpose manner enabling effectiveness, flexibility and adaptability in a dynamic and evolving business model
Broad and deep global health regulatory agency knowledge and experience across multiple GDP/GMP with current knowledge of industry trends and best practices for efficiency, compliance, and effectiveness
Knowledge of packaging and labeling requirements in the US, EU and rest of world.
Knowledge and demonstrated experience in application of risk-based quality principles in a pharmaceutical environment
Demonstrated strategic planning and execution skills required
Developing individuals and teams; proven leadership capabilities within multi-level organization
Creative, innovative leadership experience complemented with strong change management experience, adaptability, resourcefulness
Operational Excellence experience with proven ability to lead improvement projects-Experience with implementation and execution of program and enterprise risk management, Root Cause Analysis and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma
Demonstrate Vertex Phenotype qualities
Education and Experience:
Bachelor's degree in a scientific or allied health field (or equivalent degree)
Typically requires 12 years of work experience and 5 years of management experience, or the equivalent combination of education and experience
We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:
1. On-Site and work 5 days per week with ad hoc flexibility;
2. Hybrid and work remotely up to two days per week on regularly scheduled days; or select
#LI-AR1 #LI-Hybrid
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected].
Similar Jobs (5) Associate Director, Quality Packaging and Labeling Quality Operations (Cell and Gene) locations Boston, MA time type Full time posted on Posted 30+ Days Ago Director, GCP Quality Compliance, Patient Engagement and Ethics locations Boston, MA time type Full time posted on Posted 30+ Days Ago About Us Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) — a rare, life-threatening genetic disease — and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule, cell and genetic therapies in other serious diseases where it has deep insight into causal human biology, including sickle cell disease, beta thalassemia, APOL1-mediated kidney disease, pain, type 1 diabetes, alpha-1 antitrypsin deficiency and Duchenne muscular dystrophy.
Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 13 consecutive years on Science magazine's Top Employers list and one of Fortune’s Best Workplaces in Biotechnology and Pharmaceuticals and Best Workplaces for Women. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook , Twitter , LinkedIn , YouTube and Instagram .
The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives.
Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.
#J-18808-Ljbffr