I'm an Executive Quality Leader with a diverse background including:Quality Management Systems | Leadership Development | FDA 483 and Warning Letter | CAPAs | Prescription and Over the Counter (OTC) | Solid Oral Dose | Powders | Liquids | Lotions | Gels | Manufacturing Processes | Contract Manufacturing | Investigations | Complaint Handling | SOPs | Team Development | Mentoring | Process Validation | Training | Change Management | Quality Control My education and experience help me better understand manufacturing processes which provides greater insight to customer requests, investigations, or other issues as they occur. I work with raw material and component suppliers to resolve issues and evaluate changes through change management systems. I am also responsible for reviewing and approving Quality Supplier Audits and Quality Agreements as well as performing onsite audits. I truly believe that people are our best asset. I have explained processes to operators to give them a better understanding of why something was being performed a certain way. I have coached and mentored many people to help them through a difficult time, assignment, or to obtain a much deserved promotion. My best days as a leader were when I found out that someone in my groups received a promotion. I have also been responsible for Quality Control and Microbiology Laboratory operations and personnel. This has allowed me to gain valuable experience in these areas. I have used my experiences to help with out of specification investigations and raw material validations.Since my days as a soldier in the U.S. Army, I have been driven to succeed. This drive has allowed me to meet new challenges head on and conquer them. I am looking forward to discussing my next success with you.
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Director Of QualityPegasus Laboratories, Inc. Dec 2024 - PresentPensacola, Fl, Us -
Vice President Of Quality And RegulatoryDenison Pharmaceuticals Nov 2023 - May 2024Lincoln, Ri, UsLed all aspects of Quality and Regulatory to include responsibilities of Quality Assurance, Quality Control, Microbiology, Regulatory, and Batch Release groups. • Actively worked with FDA 483 and Warning Letter responses. Worked with consultants to determine best remediation plans. Ensured plan implementation based on criticality and importance.• Managed up to seventeen direct reports. Set priorities as needed to meet customer timeframes and expectations. Determined key personnel and established backups for each. Coached team members for growth and improvement. • Worked with private equity ownership and executive management team providing key updates to 483/Warning Letter, critical investigations with anticipated closure times, hiring and retention needs, and business plans.• Worked with customers to understand their concerns about Quality issues. Created numerous customer communications that detailed major events affecting their products, investigation updates, and 483/Warning Letter submission updates. -
Head Of QualityPharma Nobis, Llc (Previously Humco) Feb 2022 - Aug 2023I was responsible for all Quality Assurance and Quality Control activities. In addition I worked with other departments to assist with alternate raw material reviews and validation, investigation completion, and process improvements. I worked with contract customers to ensure the quality of their products and also with quality planning with their new product launches.
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Head Of Quality TexarkanaHumco Jun 2021 - Feb 2022Responsible for all QA and QC activities
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Interim Head Of Quality TexarkanaHumco Mar 2021 - Jun 2021Responsible for all Quality functions.
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Director Quality AssuranceHumco Oct 2018 - Jun 2021Directed and coached multiple groups including Change Management, Training, Label Control, Incoming Materials and Component Release, Document Control, Document Review, Complaints, Investigations, and Corrective and Preventative Actions. Worked with private label customers for product launches and issue resolution.Worked with internal customers to ensure timelines were met, make process improvements, and act as a resource to others. Actively participated in Health Authority Inspections and customer audits and ensured proper resolution of any observations. Worked with Validation personnel to determine best processes for both manufacturing and cleaning validations.
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Director Qa OperationsMylan 2014 - 2018Canonsburg, Pennsylvania, UsDirected and coached multiple groups to include change controls, batch record and packaging record reviews, batch documentation issuance, in-process sampling and testing, supplier and component issues, and warehouse investigations. Worked with contract manufacturers and packagers to ensure timelines were met. -
Quality Assurance Operations SuperintendentMylan 2013 - 2014Canonsburg, Pennsylvania, UsManaged and mentored the Floor Adherence Group to ensure GMPs and SOPs were complied with in the manufacturing, packaging, and physical testing laboratories. Participated in Health Authority and customer inspections. Provided team oversight and response to any incidents that occurred on the floor to determine the next course of action.
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Supervisor, Assistant Manager, Manager, Senior Manager Process ValidationsMylan 1995 - 2013Canonsburg, Pennsylvania, UsCreated and grew a team from one to a team of four. Wrote and approved all Process Validation protocols and reports for Commercial, Product Development, other Mylan facilities, and contract manufacturers and packagers. Validations included new product launches, batch size or process changes, and new equipment.
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Qa AssistantMylan 1993 - 1995Canonsburg, Pennsylvania, UsPerformed in-process sampling, physical testing, and cleaning validation swab collection.
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SpecialistUs Army 1985 - 1987Arlington, Virginia, Us
Robert Watts Skills
Robert Watts Education Details
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The University Of AkronMechanical Engineering
Frequently Asked Questions about Robert Watts
What company does Robert Watts work for?
Robert Watts works for Pegasus Laboratories, Inc.
What is Robert Watts's role at the current company?
Robert Watts's current role is Executive Quality Leader.
What schools did Robert Watts attend?
Robert Watts attended The University Of Akron.
What skills is Robert Watts known for?
Robert Watts has skills like Standard Operating Procedure, Pharmaceutical Industry, Gmp, Good Manufacturing Practice, Leadership, Quality Assurance, U.s. Food And Drug Administration, Management, Change Management, Microsoft Office, Team Leadership, Process Validation.
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