Vice President of Compliance
Let’s Make Things Happen!
Ajinomoto Althea, Inc. is a fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global biotechnology and pharmaceutical companies.
Althea is a leading expert in aseptic filling of drug product in vials and syringes, and our focused expertise and capabilities make us one of the industry’s top leaders for cGMP microbial fermentation of recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive development services including: upstream and downstream process development, complex formulations, lyophilization cycle, analytical development, product release and ICH-compliant stability testing.
Now is an exciting time to join Althea. We have talented people working together to help our clients advance their innovative product pipelines. We believe that people are our greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth.
Our work atmosphere is fast paced, stimulating and customer focused. Employees take pride in knowing our efforts are helping countless patients for years to come.
Althea is currently seeking a Vice President of Compliance. As a member of the executive team, the VP of Compliance is responsible for providing company direction and strategy in the areas of Compliance, Quality Assurance, Regulatory Affairs, Operational Excellence and EH&S. This position manages company activities in order to maintain compliance with the FDA, Notified Bodies and state, federal and international regulations.
- As a member of the Senior Management team works alongside other executive team members in developing and executing the company’s global strategic plans.
- Develops compliance strategies, plans and budgets to meet the company’s business objectives.
- Manages external quality and regulatory relationships with the FDA, other regulators and Notified Bodies.
- Maintains safe and ethical business practices and adheres to Althea’s Quality Policy, ensuring that it is fully embraced across the organization and that initiatives are established for adherence to the Quality Policy at all levels of the organization.
- Interfaces with regulatory agencies, and customers to build relationships and address issues identified for improvement or resolution.
- Establishes and communicates high performance standards, defines clear accountability, and leads by adopting improvement strategies to reduce operational variances and increase efficiency.
- Directs activities pertaining to assuring compliance, including development, implementation, maintenance and performance of quality assurance systems and programs.
- Responsible for managing department budget.
- Provides guidance to QA, QC, Validation, Regulatory, OE, and EH&S leadership.
- Determines acceptability of manufacturing batches for release and assigns final disposition.
- Builds the future of the organization through developing people, organizational capabilities, and the culture of Althea.
- Drives successful manufacture and delivery of high quality products to customers.
- Embodies Althea’s cultural values by aligning daily actions with department goals and company culture.
- Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Bachelor’s degree in a Life Sciences discipline or equivalent discipline required. Doctoral degree (PhD, MD or equivalent) is strongly preferred.
- Prior experience in Compliance is required. Experience across different sized organizations (such as both biotechnology and pharmaceutical companies) is strongly preferred.
- Prior experience at multi-product facility with different pipelines of products strongly preferred.
- Prior experience with different quality and regulatory requirements for disparate types of products strongly preferred.
- Working knowledge and understanding of drug development.
- Well-developed negotiation skills.
- Minimum of fifteen (15) years of experience in quality assurance, regulatory, manufacturing, or laboratory.
- Minimum of six (6) years of experience leading a quality and regulatory organization.
- Expert knowledge of GLP and GMP regulations and good documentation practices.
- Knowledge of industry standards and regulation requirements for biologics and parenteral products in clinical and commercial products.
- Demonstrated ability to successfully interface with and provide guidance to multi-disciplined teams from project inception through project completion with respect to FDA requirements, agency and vendor audits, corrective actions, and complaint management.
- Thorough knowledge and understanding of FDA and EMA requirements.
- Extremely detail oriented with strong analytical, written and verbal communication skills.
- Must be familiar with Microsoft Office applications.
- Able to deliver compelling presentations to industry executives.
- Develops short and long-term people and organizational strategy in alignment with Althea goals and direction.
- Leads with impact & influence. Establishes credibility, effectively persuades and develops others, and achieves important objectives collaboratively.
- Drives strategic change and promotes improvements within the organization.
- Identifies, recruits, and retains top-notch talent.
- Champions Althea’s culture and empowers employees to take responsibility for their jobs and goals.
- Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
- Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication.
If you meet the requirements above, and would like to apply for this position, please visit our website at www.altheacmo.com and click on the "Careers" section. Please be sure to note where you saw our ad posting.
We are an EOE dedicated to a diverse work force and Drug Free work environment.
Qualified M/F/D/V candidates are encouraged to apply.