Surmasis Pharmaceutical - Director of Quality | M-F | Pay Based on Experience

Shift: First Shift,Mon,Tue,Wed,Thu,Fri

Directs all quality functions at Surmasis to assure that all products manufactured by the organization meet customer specifications and regulatory requirements and achieve superior quality and reliability levels. This position is hands-on and very involved in the day-to-day operations of the Quality Department functions of Surmasis as a Pharmaceutical Drug contract manufacturer. Products within the scope of the company include, but are not limited to, topical/transdermal products, such as patches, creams, lotions, and ointments. Activities of the job may include, but are not limited to, batch releases, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management and regulatory interactions, either directly or through direct reports.

• Acts as a key contributor to the overall quality direction of the company. Communicates and works together with other management at Katecho to maintain and improve the direction of the company.
  
• Develops and implements the quality assurance and quality control programs at Katecho to ensure conformity of processes to established quality standards.
  
• Maintains a high level of understanding of relevant production processes and quality systems related to 21 CFR 210/211 and Part 820 (applicable sections for combination products).
  
• Reports to management on the performance of the QMS and the avenues for improvement.
  
• Performs the QA review and approval of the following GMP documentation as it relates to the processing equipment and facility to which the position is aligned: Change Requests, Batch Records and associated documentation, Product and Component Release, Quality Investigations (Deviations, Product Complaints), Validation Plans, Protocols and Reports, Standard Operating Procedures
  
• Collaborates with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems.
  
• Executes QA processes including batch record review, product disposition and quality issue resolution to maintain the flow of products and documents to meet site objectives.
  
• Facilitates process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient and effective practices.
  
• Stays abreast of evolving regulatory compliance practices and recommends implementation strategies to site leaders.
  
• Oversees Supplier Management, including but not limited to, Annual Assessments, Quality Assurance Agreements, and KPI�s.
  
• Collaborates in data analysis and report creation on quality metrics and key performance indicators.
  
• Regular and reliable attendance is an essential function of this job. Punctuality and regular attendance are crucial for efficient plant operations, safety, and morale.
  

• Strong collaboration with the other regional and global sites to ensure consistent application of quality systems / processes across the site.
  
• Self-motivated, demonstrates leadership, and works independently with minimal guidance from management.
  
• High level of proficiency in problem-solving, creativity, independent thought, and sound judgment.
  
• Influence in team and project meetings, advising project teams with respect to quality solutions and potential new approaches for consideration.
  
• Training and mentoring of other members of the organization.
  
• Strong performance history of consistently meeting and exceeding expectations.
  
• Other duties and responsibilities may be assigned as required.
  

• Bachelor�s degree in a science/technical field such as Pharmacy, Biology, Chemistry, or Engineering or any bachelor�s degree with three years of experience in pharmaceutical industry in roles covered by GMP oversight.
  
• Excellent oral and written communications skills.
  
• Strong ability and motivation to learn.
  
• Minimum of five years of experience in the pharmaceutical industry and/or FDA experience with at least a minimum of three years of experience in Quality Assurance/Compliance.
  
• Preferred minimum of seven years of experience in QA/Regulatory Compliance in the p pharmaceutical industry.
  
• Strong knowledge of global regulatory and cGMP requirements, industry best-practices.
  
• Strong familiarity with production operations.
  
• Strong leadership, project management, and technical writing.
  
• Strong interpersonal, communication, and influencing skills.
  

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to stand, walk, sit, and operate a computer. Specific vision abilities required by this job include close vision and distance vision.

Office environment with business casual dress. May require business attire.

At Surmasis, we’re proud to offer a comprehensive benefits package, including:

• Medical Insurance - PPO & HMO plans
  
• Dental and Vision Coverage
  
• Flexible Spending Account (FSA)
  
• Life Insurance Options
  
• Short-Term and Long-Term Disability (STD/LTD)
  
• 401(k) Retirement Plan
  

We believe in taking care of our team-so you can focus on doing your best work.

From: Katecho