Advantage Solutions Director QA Regulatory Affairs in United States

Summary

Director QA Regulatory Affairs

The Director QA Regulatory Affairs will be responsible for all aspects of Quality Assurance and Regulatory Affairs as it relates to Drugs, Natural Health Products, and Medical Devices that are imported and/or distributed by ASM Canada. This role will be the sole decision-maker for all issues of quality or regulatory nature, and be the primary contact for all dealing with Health Canada.

Responsibilities

Advantage Sales and Marketing LLC dba Advantage Solutions is one of North America’s leading sales and marketing agencies specializing in outsourced sales, merchandising, category management and marketing services to manufacturers, suppliers and producers of food products and consumer packaged goods. Advantage Solutions services a variety of trade channels including grocery, mass merchandise, specialty, convenience, drug, dollar, club, hardware, consumer electronics and home centers. We bridge the gap between manufacturers and retailers, providing consumers access to the best products available in the marketplace today.

Position Summary

The Director QA Regulatory Affairs will be responsible for all aspects of Quality Assurance and Regulatory Affairs as it relates to Drugs, Natural Health Products, and Medical Devices that are imported and/or distributed by ASM Canada. This role will be the sole decision-maker for all issues of quality or regulatory nature, and be the primary contact for all dealing with Health Canada.

Essential Job Duties and Responsibilities

Regulatory Affairs:

• Keep an up-to-date knowledge on company and Health Canada regulations and policies applying appropriate implementation strategies where required.

• Prepares and reviews regulatory documentation and submissions to regulatory bodies including, but not limited to: Drug Establishment Licenses, and Site Licenses/registrations.

• Prepares regulatory submissions, inventory reports, and coordination of responses to Health Canada

• Knowledge of provincial scheduling, Formulary, Pest Management Regulatory Agency (PMRA) preferred but not required.

Quality assurance:

• Conduct review of and track GMP documentation, including Master Batch Records, Certificates of Analysis, Annual Product Reviews, Stability, etc., for products marketed.

• Drafts, revises and implements company procedures, policies and quality documents to ensure compliance across all departments.

• Trains all personnel with QC and QA principles.

• Performs all QA functions including, but not limited to: batch/lot record review and release, raw data review, deviation/failure investigation, change evaluation, product sampling, and retention.

• Reviews production and laboratory records, assisting in internal audits and self-inspections.

• Supports in the development of SOPs to ensure efficient and compliant External Quality function.

Supervisory Responsibilities

Direct Reports

  • This position does not have supervisory responsibilities for direct reports

Indirect Reports

  • May delegate work of others and provide guidance, direction and mentoring to indirect reports

Travel and/or Driving Requirements

  • Travel and Driving are essential duties and function of this job

  • Travel up to 10 %

Minimum Qualifications The following are the minimum job-related qualifications which an individual needs in order to successfully perform the essential duties and responsibilities of the job

Education Level: (Required): Bachelor's Degree

Field of Study/Area of Experience: Chemistry, chemical engineering, biochemistry, physical sciences, life sciences, pharmacology or pharmacy

10+ Years of experience in regulatory affairs, compliance, quality assurance, and document management in the pharmaceutical or non-prescription drug industry or equivalent

Experience in an environment adhering to federal governmental regulation (i.e: Health Canada, PMRA, Consumer Products, etc.).

Strong GMP pharma/ Qualified Person in Charge (QPIC) experience.

Prior experience interacting with auditors and regulators.

Experience in document control and management.

Knowledge of country-specific regulatory requirements is an asset. Experience with preparing regulatory submissions is an asset.

Skills, Knowledge and Abilities

• Strong ability to understand and analyze technical documents, processes, regulations, industry standards, procedures, and processes. Excellent communication skills. Analytical, methodical and diligent with outstanding planning abilities.

• Ability to effectively work both independently and in a team environment

• Superior time management and organizational skills

• Excellent knowledge of current good manufacturing regulations as applicable to the pharmaceutical industry, specifically FDA and Health Canada .

• Ability to effectively work both independently and in a team environment

• Superior leadership, time management and organizational skills

Environmental & Physical Requirements

Office / Sedentary Requirements

Work is performed primarily in an office environment.

Additional Information Regarding ASM Job Duties and Job Descriptions

The Company is committed to providing equal opportunity in all employment practices without regard to race, nation or ethnic origin, colour, religion, age, sex (including pregnancy and childbearing), sexual orientation, marital status, family status, physical or mental disability or pardoned criminal convictions, or any other category protected by law.

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position. The Company reserves the right at any time with or without notice to alter or change job responsibilities, reassign or transfer job position or assign additional job responsibilities. The Company shall provide reasonable accommodations of known disabilities to enable a qualified applicant or employee to apply for employment, perform the essential functions of the job, or enjoy the benefits and privileges of employment as required by the law.

Employee understands that neither the provision of the Job Description nor any representation in this document creates a guarantee or contract of employment for any specified period of time or changes the nature of Employee’s employment, which can only be modified in a writing signed by the CEO.

Important Information

The above statements are intended to describe the general nature and level of work being performed by people assigned to this position. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of associates so classified.

The Company is committed to providing equal opportunity in all employment practices without regard to age, race, color, national origin, sex, sexual orientation, religion, physical or mental disability, or any other category protected by law. As part of this commitment, the Company shall provide reasonable accommodations of known disabilities to enable an applicant or employee to apply for employment, perform the essential functions of the job, or enjoy the benefits and privileges of employment as required by the law.

The Company welcomes and encourages applications from people with disabilities. The Company will provide reasonable accommodations, accessible formats and communication supports upon request to persons with disabilities who take part in all aspects of the recruitment and selection process. If you require accommodation in connection with the application process, please contact: Recruiter, Talent Acquisition, for external applicants, or, a Supervisor for internal applicants.

Position Type Full Time

Postal Code L3R 4B8

Requisition ID 2018-194809

Category Professional: (IT, Finance, Legal, HR, Talent Acquisition, Administrative, Customer Service)