Sr. Manager RD Quality
Adare Pharma Solutions, United States
Job Description
Are you ready to join agrowing, global drug development and manufacturing organization that puts people first? Come to Adare! We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world. Each role and every department within Adare offer you a unique, customized experience with a chance to make a real impact, and is critical to our success. With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery!
Join our mission at Adare!
What can Adare offer you?
- Medical/dental/vision/life low employee premiums
- 401k with a highly competitive match
- Generous PTO, including floating holidays
- Career growth and internal opportunities
- Tuition reimbursement
- Relocation assistance
- Performance-based bonus
- Employee Recognition Programs
We are seeking to hire a Senior Manager, Ramp;D Quality to join our Quality team
If any of the below describes you, we would love to meet you!
JOB SUMMARY
The Senior Manager Ramp;D Quality reports to the Director of Quality Assurance, and supports Research and Development by being a dedicated quality resource to support the quality needs of the Ramp;D Department with focus on pre-commercial GMP product. The Sr. Manager Ramp;D Quality will also work with Sr. Manager, Quality Operations in managing the Quality Operations staff, which include multiple QA Technicians.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES
- In coordination with Sr. Manager, QA Operations, manages combined specialist personnel
- Responsible for management of Quality Operations staff in the absence of the Sr. Manager, Quality Operations
- Is a backup resource to the QA team that focuses on commercial product as needed by the Quality Director
- Ensures Quality Systems (CAPA, Non-Conformance, Trending, Data Integrity, Customer Complaints, Change Control, etc.) compliance and drives improvements specifically for Ramp;D
- Provide guidance and ensure corrective and preventive actions are adequately and timely implemented and monitor their closure and effectiveness
- Support the Ramp;D department in the evaluation of department SOP’s to drive efficiency and quality by design
- Oversees the review and approval of development batch records for non-commercial GMP batches (clinical batches, tech transfer batches, for example)
- Reviews and approved Design of Experiment and Critical Process Parameter Reports
- Reviews and approves all quality related documentation produced by Ramp;D, including sampling protocols, stability protocols, test method qualification and validation reports.
- Reviews and approves investigations generated by Ramp;D
- Participates in internal audits of the Ramp;D department
- Participates in developmental customer internal and external planning sessions
- Interact with Customer’s Quality associates to fulfill client needs
- Participate in Customer/Regulatory audits as needed
- Conducts investigations to determine root cause and recommends amp; implements corrective, preventive
- Collaborate with all departments within the company as required
- Ensure facility adherence to cGMP’s and SOP’s with special focus on Ramp;
- Other duties as assigned
Requirements
REQUIRED SKILLS AND QUALIFICATIONS
- BS/BA degree from a four-year accredited university or college.
- 8+years of related experience preferred.
- Advanced knowledge GMPs specifically clinical GMP’s
- Understanding of Quality Systems pertaining to a bulk pharmaceutical, solid oral dosage manufacturing and packaging environment is preferred.
- Operational knowledge of European GMPs.
- Excellent document quality.
- Able to prioritize duties and manage multiple activities from start to finish with minimal supervision.
- Exceptional attention to detail and excellent organizational skills.
Benefits
- Medical/dental/vision/life low employee premiums
- 401k with a highly competitive match
- Generous PTO, including floating holidays
- Career growth and internal opportunities
- Tuition reimbursement
- Relocation assistance
- Performance-based bonus
- Employee Recognition Programs
Adare Pharma is an equal opportunity employer amp; prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disabil