Job Description
Description
Key Responsibilities:
- Collaborate with Management to establish and report targets and timelines.
- Serve as the Quality representative on cross-functional and multi-site teams.
- Identify, design, and implement process and system improvements.
- Train personnel on relevant business processes.
- Use Operational Excellence tools (e.g. Six Sigma, Lean) to analyze current state and create future state.
- Cultivate connections across the company and promote a culture of continuous improvement.
- Generate procedures and other documents as appropriate to meet project deliverables
- Solve a wide range of difficult issues that impact multiple functions, following cGMP regulations and company standards.
- Follow company policies and procedures.
- Perform other duties as assigned.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. The job description, shown above, is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
Occasional overnight travel by land and/or air may be required to attend seminars or conferences.
Preferred Qualifications:
- B.A. or B.S. degree (preferably in Life Science)
- 10+ years’ experience in the pharmaceutical or biotechnology industry, or an equivalent combination of education and experience, with five years in quality assurance.
- Preferably a minimum of three years of supervisory/management experience.
- Sound knowledge of cGMPs and equivalent regulations.
- Ability to communicate clearly and professionally both in writing and verbally.
- Six Sigma Black Belt Certification and 3+ years Operational Excellence experience preferred.
- You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
- You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
