Sr. Manager, Quality

Objective

Under general guidance, will develop and implement department goals, objectives, and systems to ensure the achievement of company objectives.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

1. Direct and coordinate the activities of Quality Control and Quality Assurance and its functions to ensure achievement of company objectives as well as resolve problems; work with other departments to accomplish the same.
2. Lead and play a significant role the ensuring that the Company is compliant with cGMP, ISO13485, 21 CFR 211 and 820 and any other applicable regulations for the manufacturing, marketing, sale and or distribution of Drugs, Medical Devices, and Cosmetics.
3. Through subordinate supervisor, manage quality control processes by confirming conformance to product specifications and quality attributes.
4. Oversees Quality Engineering duties associated with the design, implementation and improvement of manufacturing processes and projects of major complexity to improve quality and yields.
5. Execute Management Reviews and Annual Product Reviews in accordance with requirements and the Company’s Quality Management system.
6. Identify technical opportunities and recommend projects to management for implementation.
7. Assists in the development of drawings and specifications for existing products, raw materials, and components.
8. Assists in the qualification of new, modified or substitute raw materials and components, critical suppliers, processes, and/or products.
9. Designated Management Representative for Company. May be asked to represent the company in matters related to notified bodies and regulatory agencies, up to and including MDSAP, EUMDD/MDR, and ISO 13485.
10. Monitor changes in standards across all key markets including the U.S., the E.U., Canada and other territories.
11. Support all manufacturing related Lean, 5S and Six Sigma initiatives.
12. Coordinate implementation of new product processes from R&D into the manufacturing environment. Develop, manufacture, and test prototypes of new design or design modifications as a member of Product Development System teams. Validate new/modified processes with assistance from QA.
13. Ensure that all Drug products have the appropriate development history documentation, comprehensive Master Production Records and that Batch Production Records are properly maintained.
14. Confer with and provide direction for vendors and suppliers to arrange for purchase of equipment, material and parts required to carry out manufacturing process activities or to provide analytical capabilities in support of manufacturing process activities.
15. Oversee Quality Engineering technical support for regulatory submissions including US 510(k)’s and EU Technical File documentation.
16. Direct Quality Assurance product failure root cause analysis.
17. Project management including plans, budgets, schedules and tracking to insure completion on time and within budget.
18. Furnish outline of tasks or projects to other technical staff below this grade. Provide necessary information or contacts to initiate task or project. Monitor performance of tasks or projects. Coordinate parallel activities of other technical support departments. Publish results of activities.
19. Evaluate current procedures and practices for accomplishing department objectives and develop and implement improved procedures and practices.
20. Analyze and monitor department costs.
21. Initiate personnel actions, including employee hires, promotions, transfers, and discharges.
22. Create and present employee evaluations, subject to the approval of the COO.
23. Assess subordinate employee training needs and conduct or recommend training as necessary.
24. Administer employee disciplinary actions as the situation requires.
25. Demonstrate a high standard of work ethics and professionalism to at all times.
26. Represent the company in a positive and supportive manner at all times

Additional Duties and Responsibilities include the following. Other duties may be assigned.

1. Provide Sales and Customer Service, and other departments as necessary with technical support for internal and external customers.
2. May travel for business including overnight travel as necessary.
3. Other tasks as assigned.

Supervisory Responsibilities

Carries out supervisory responsibilities, if applicable, in accordance with the organization’s policies and applicable laws. Responsibilities include hiring; delegating and conducting training; assigning, reviewing, and approving work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Education and/or Experience

BS degree in Engineering or related field and 5-8 years operational/manufacturing/quality assurance experience with quality focus in drug manufacturing. A minimum of five years of experience in the drug manufacturing industry required; or equivalent combination of training and experience. Individual must possess the ability to be recognized as a technical expert and internal consultant to DenMat.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

The requirements listed below are representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the described functions.

Language Skills

Ability to read, analyze, and interpret general business periodicals, professional journals, technical journals and procedures and governmental regulations. Ability to write reports, business correspondence, documentation and procedures. Ability to effectively present information and respond to questions from groups of managers or technical peer groups.

Mathematical Skills

Ability to comprehend and apply principles of calculus, algebra, and advanced statistical theory.

Computer Skills

Ability to use word processing, spreadsheet and database applications. CAD experience strongly preferred. Ability to learn various software programs.

Certificates, Licenses, Registrations

None required.

Knowledge, Skills and Abilities

Knowledge of International Drug and device regulations including, but not limited to 21 CFR 211, ISO 13485, Council Directive 93/42/EEC (Medical Device Directive), and the Canadian Medical Devices Regulations.

Knowledge of regulatory requirements that relate to process design.

Knowledge of medical device or drug manufacturing.

Ability to demonstrate leadership in job performance by example.

Ability to function and be recognized as a technical expert and internal consultant to DenMat.

Ability to provide work direction, and to guide and delegate to technical staff.

Ability to provide objective input to management regarding the performance of technical staff.

Ability to present facts and recommendations effectively in both oral and written form.

Ability to interface with many levels of employees of various disciplines within various departments.

Ability to maintain accuracy, consistency and quality of documentation and projects while managing assignments in a fast-paced, multi-task environment.

Ability to function in a controlled environment under domestic and international regulations and handle extremely confidential data.

Ability to interact and negotiate successfully with suppliers and vendors.

Ability to take initiative and make decisions within department/company guidelines.

Ability to analyze training needs and conduct training.

Ability to work in a team environment with other engineers and technicians.

Ability to accurately perform detail-oriented work.

Ability to coordinate work activities of others as directed.

Ability to prioritize and manage concurrent projects.

Ability to use word processing, spreadsheet, and database computer applications, and to learn various software programs.

Physical Demands and Work Environment

The physical demands and work environment characteristics 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 regularly required to sit, talk and hear and use hands repetitively. The employee is occasionally required to stand, walk, and use stairs; lift and/or move up to 25 pounds; is exposed to moving mechanical parts, and dust and organic fumes such as xylene and isopropanol; and may be required to wear protective personal equipment such as gloves, mask, safety goggles, etc. Normal 20/20 vision ability (with corrective lenses, if needed) is required by this position. The noise level in the work environment is usually moderate.

The posted range for this position is $85,000-$115,000 annually which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including education, prior experience, training, current skills, certifications, location/labor market, internal equity, etc.

DenMat offers a complete benefits package, including medical/dental/vision/Rx, Life, 401(k) with matching, 10 paid company holidays, vacation and sick time, bereavement, EAP, and employee discounts.

DenMat participates in E-Verify.

DenMat Holdings, LLC is an Equal Opportunity/Affirmative Action Employer; employment with DenMat is governed on the basis of merit, competence and qualifications and will not be influenced in any manner by race, color, religion, creed, national origin/ethnicity, veteran status, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital status, or any other legally protected status.