Manager, Regulatory Compliance - United States
What differentiates us at Alcami? Our people.
Help shape the future of medicine and join us – we are a pharmaceutical contract development manufacturing organization (CDMO).
Alcami Corporation is the first company to offer a solution that is tailored to small and mid-size pharmaceutical and biotechnology companies. We offer a range of services from four distinct pillars: Development Services, Analytical Testing, Drug Product, and APIs. Beyond that, we can integrate our services so customers experience a simplified engagement with a single project management relationship, full visibility from development into manufacturing, and shorter turnaround times. With six locations in the U.S. and a global location in The Netherlands, the Alcami family is growing rapidly. Picture yourself at Alcami and apply today.
This position is located at our Wilmington, NC and just minutes from beautiful Wrightsville Beach, Wilmington is a vibrant city that boasts a variety of cultural resources, a strong business climate, and a family-oriented environment. Wilmington is home to the University of North Carolina Wilmington, one of the top-ranked southern public universities. Wilmington has been recognized as one of the “The Best Places to Live” (Money Magazine) and ranked #13 as “Best Places for Business and Careers” (Forbes Magazine).
Manages the compliance group that is typically staffed by professional, salaried employees performing quality compliance functions. Interacts with clients and regulatory agencies as needed regarding quality issues, audits, and inspections.
As the Manager, Regulatory Compliance you will:
- Direct the development of short and long range goals and objectives, and assure that year-end goals are attained.
- ensure that departmental processes and standards are in line with regulatory guidelines.
- ensure that departmental performance and personnel qualifications meets the expectations of customers (internal and external) and support the achievement of broader business goals.
- ensure that department activity is coordinated with departments within and outside of QA.
- provide regular feedback and will perform annual performance evaluations for direct reports. They will require and monitor training for subordinate management staff and other direct reports. They will train and develop them to their potentials. Managers are responsible to foster teamwork and positive approaches to problem solving.
- initiate employee hire, promotion, discharge, or transfer and will participate in the selection process for subordinate personnel.
- provide encouragement and positive reinforcement to subordinates and require subordinate management staff to do the same.
- understand and communicate cascade communication from Executive management.
- have departmental financial accountability and will assist in the preparation and administration of budgets and monitor and analyze cost against budget.
- maintain operational metrics and financial results to identify actions to improve performance.
- be responsible for the effective implementation of harmonized compliance procedures across all sites.
Qualifications for success:
Minimally Bachelors with 13+ years industry related experience, including 5+ years management experience. Experience level applies to all degrees.
- Extensive knowledge of regulatory requirements applicable to areas managed.
- General knowledge of processes applicable to subordinate groups.
- Awareness of industry trends related to areas managed.
- Excellent problem solving skills.
- Consistent attention to details.
- Excellent leadership skills.
- Excellent performance management and employee development skills.
- Excellent time management skills.
- Excellent organizational skills.
- Excellent presentation skills.
- Ability to multi-task.
- Computer proficient.
- Good understanding of hiring and employment practices.
- Strong understanding of financial and budget concepts.
- Ability to train and mentor others.
- Excellent written and verbal communication skills.
- Able to work effectively with employees at all levels.
Travel: Some domestic and international travel may be required.
What we offer you:
- In Wilmington, an onsite Learning Center for working parents
- Profit sharing bonus plan
- Medical, dental and vision coverage from day one
- A menu of voluntary benefits including short & long term disability, life, accident, critical illness and hospital indemnity insurances
- Paid/flexible sick-leave, vacations, and holidays so you can take the time when you need it
- To complement your personal financial strategy, we also have 401(k) matching