Vice President
2 weeks ago
**McGuff Pharmaceuticals, Inc. - Vice President**
McGuff Pharmaceuticals, Inc. is a family of companies located in Santa Ana California, specializing in the manufacture of sterile injectable drug products, for distribution both within the United States and internationally. Our mission as a pharmaceutical manufacturer is to retain our uncompromising passion for quality pharmaceuticals and customer satisfaction. We strive to remain ahead of the innovative and maintain full compliance in a field of rapidly changing regulations, while upholding a high standard for safe, effective, and reliable products. McGuff Pharmaceuticals is currently seeking a Vice President and Director of Operations to enhance its team
**Job Details**
McGuff Pharmaceuticals, Inc. currently has an opening for a Vice President in Santa Ana, CA.
The Vice President will be responsible for coordinating, leading, and managing an FDA approved cGMP manufacturing facility producing sterile drugs. The Vice President and Director of Operations will oversee department managers reporting direction to the President of McGuff Companies.
- Ability to effectively lead, manage, and teach the leaders of teams.
- Be part of a cohesive and supportive management team to ensure company success into the future
- Define and set the company goals, develop a plan to meet/exceed those goals, and execute.
- Ability to identify and adapt to a new situation, pivot, and attack the problem.
- Review medical journals, publishing, state and federal guidelines to correctly anticipate the future direction of the government (state and federal) and industry requirements.
- Pharmaceutical cGMP manufacturing knowledge and assist with live cGMP audits to identify and prioritize facility and process compliance issues
- Pharmaceutical quality assurance/control knowledge
- Participated directly in inspections from government agencies
- Ability to identify bottlenecks and the critical path within a process
- Lead training and coaching of managers and personnel
- Develop and implement internal training programs through Master Control (MC).
- Contract review / development / maintenance
- Ability to ask the right probing questions to identify shortcomings
- Knowledge of 503B
- Knowledge of pharmaceutical laboratory operations
- Knowledge of the process of developing a new product
- Knowledge of building new pharmaceutical manufacturing capability.
- Knowledge of Contract Development and Manufacturing Operations (CDMO / CMO)
- Problem solving and business development with executive team
- Most important: CAN DO ATTITUDE
**Essential Functions and Duties shall include**:
1. Responsible for coordinating and implementing activities related to future and ongoing regulatory compliance:
2. Oversee McGuff Pharmaceuticals Inc. reporting directly to McGuff Companies President / Management team.
**Minimum and Preferred Qualifications shall include**:
1. Education: Master’s degree in related field, preferably in a scientific, business or technical discipline.
2. Minimum of 10 years relevant industry experience.
3. Experience with cGMP manufacturing of finished dosage form pharmaceutical manufacturing and clinical trials or equivalent, preferred.
4. Thorough understanding of FDA regulations.
5. Effective research and analytical skills.
6. Knowledge of cGMP requirements.
8. Computer literate and familiar with computerized documentation and database methods, tracking and control systems.
9. Ability to manage multiple projects.
10. Excellent written and oral communication, technical writing and editing skills.
**What Is Expected of You**:
1. Appropriate professional demeanor.
2. Knowledge, understanding and compliance of the dress code and corporate policies.
3. Ability to work with others.
4. Excellent communication skills.
5. Excellent customer skills
6. Work with all McGuff employees to foster/promote quality and team spirit throughout all organizations.
7. Will rely on extensive experience and judgment to plan and accomplish goals.
8. Ability to work independently with mínimal supervision and in team setting to perform a variety of tasks.
9. Individual creativity and latitude for goal attainment is expected.
**Why McGuff Pharmaceuticals, Inc.?**
The McGuff family of Companies provides pharmaceuticals, medical devices, nutraceuticals, and services used daily by many leading healthcare professionals and organizations. McGuff Pharmaceuticals, Inc specializes in the manufacture of high quality sterile injectable drug products for sale both domestic and internationally.
McGuff’s fifty years of success is built on an innovative corporate culture, upheld by its skilled employees, working to understand and always meet customer needs. In a world of rapidly changing science and regulations, our goal is to retain consistent and reliable relationships with our valued customers. McGuff customer support teams engage their customers in a friendly and informative environment, to off
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