Careers at ARG

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Allergy Research Group, established in 1979, is an innovative leader in research and the formulation of nutritional supplements. The Company is recognized worldwide for the quality, purity and efficacy of its targeted nutritional supplement line consisting of more than 300 products. Over 6,000 physicians and health care practitioners worldwide currently purchase Allergy Research Group's products and recommend these supplements to their patients.

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Director - Quality / Regulatory Affairs

Location: Alameda, CA
Benefits Offered: Vision, Medical, Life, Dental, 401K
Employment Type: Full-Time
Title: Director of Quality & Regulatory Affairs - Reports to President Directly

ARG offers a competitive compensation structure and a comprehensive benefit package which includes medical, dental and vision plans from tier one companies, Paid Time Off, 401k match and company-paid disability and life insurance. ARG employees also enjoy a wide array of unique benefits such as employee discounts and wellness programs.

POSITION SUMMARY: The Director of Quality & Regulatory Affairs manages all aspects of the Technical Services Group.

1. Regulatory Strategy

  • Review, fine-tune and further develop ARG’s regulatory strategy in order to maximize contributions towards ARG’s overall goals
  • Create and implement frameworks and processes that will allow timely market entry of product candidates
  • Liaise with industry associations and regulatory bodies in order to secure maximum regulatory compliance

2. New Product Development Support - Render Regulatory and Quality Support for

  • ARG’s R&D activities
  • Review of new third party product opportunities
  • Out-licensing or other partnering models
  • Development of proprietary platform technologies

3. Compliance

  • Ensure ARG meets or exceeds all regulatory requirements including all aspects of cGMP
  • Manage all relevant aspects of post-marketing surveillance including dialogue with relevant stakeholders
  • Maintain adequate records and documentation of all regulatory matters and QA/QC matters
  • Maintain necessary internal systems and procedures
  • Lead and coordinate corrective actions shall post marketing deficiencies become known
  • Manage and qualify vendors and their compliance

4. Others

  • Support other activities such as quality assurance, labelling reviews and promotional material creation
  • Carry out supervisory responsibilities including interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems in accordance with the organization's policies and applicable laws

QUALIFICATIONS: 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. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and EXPERIENCE

  • Bachelor’s degree from an accredited college or university in Life Sciences field; master’s or doctorate degree preferable
  • Minimum seven years related experience in Quality Control, Quality Assurance and/or Regulatory Affairs in a drug, OTC or dietary supplement FDA GMP setting; or equivalent combination of education and experience
  • A minimum of three years’ experience in supervision of Quality Assurance, Quality Control and/or Regulatory Affairs staff
  • Experience in internal and external auditing, change control procedures, and GMP compliance and enforcement
  • Up to date in-depth knowledge of cGMP essential

LANGUAGE SKILLS: Ability to read, analyze, and interpret general business publications, professional journals, technical procedures, or governmental regulations. Strong ability to write reports, reviews, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

MATHEMATICAL SKILLS: Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

OTHER SKILLS AND ABILITIES

  • Forward looking strategic thinker able to help shape and implement the ARG vision
  • High ethical level; principle-centric with pragmatic implementation
  • A team player able to work collaboratively and successfully across functions
  • In-depth understanding of regulatory requirement needs across product categories
  • Exceptional interpersonal and relationship building skills
  • A strong, motivating team leader with experience in building highly effective teams and developing talent
  • Experience in communicating effectively
  • Positive, enthusiastic, self-motivated with a high energy level
  • Excellent problem solving skills
  • Rapidly adaptable to a changing environment and willingness to assess and implement new ideas and opportunities
  • Excellent English oral and written communications skills
  • Attentive to detail
  • Ability to undertake situations with a proactive and “hands-on” approach
  • Commitment to lifelong learning and willingness to continuously upgrade skill set to excel at the requirements of the position
  • Agile in the use of office software, systems and communication platforms
  • Ability to train all levels of personnel in a manufacturing environment
  • Passion for a healthy lifestyle

SAFETY RESPONSIBILITY STATEMENT

  • Responsible for safety performance in respective areas
  • Supports a culture of safe production and operations; follows all workplace health and safety procedures
  • Ensures the implementation of, adherence to, and enforcement of workplace health and safety requirements
  • Ensures activities are completed to promote and enforce safe behaviors by supervisors, employees and vendors
  • Ensures injury prevention efforts are effectively implemented. Fulfills responsibilities as outlined as per the company safety section in the employee manual

PHYSICAL DEMANDS: 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.

WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee is potentially exposed to airborne particles and/or odors associated with standard laboratory work. The noise level in the work environment is usually moderate. It is the policy of ARG to prohibit discrimination of any type, and to afford equal employment opportunities (EEO) to all employees and prospective employees, without regard to race, color, religion, gender, national origin, age, disability, sexual orientation or any other characteristic protected by law. The position is a full-time exempt position.

APPLICATION PROCESS: To apply for this position, please Contact Us to send resume and cover letter.

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