Regulatory Compliance Coordinator jobs in Bethlehem, PA

SUMMARY

The Director of Compliance & Regulatory Affairs leads a cGMP, FDA and DEA compliance program for Sharp’s three US Commercial Packaging locations in Pennsylvania. Reporting to the VP Quality for Sharp’s US Commercial Packaging business, the position has responsibility for:

• Driving, owning and being the subject matter expert in cGMP and FDA regulations and inspection readiness programs at Sharp’s facilities.
• Participating in regulatory agency inspections as required.
• Upkeep of federal, state, and international agency registrations, licenses, compliance filings (including drug listings) and addressing customer/regulatory agency document requests.
• Managing all DEA reporting activities.
• Leading a Supplier Quality Management program.
• Managing a customer audit program that includes authoring audit responses to the customer.
• Managing an internal audit program of Sharp’s US Commercial Packaging facilities.
• Managing the development/upkeep of Quality/Technical Agreements between Sharp and its customers.
• Setting the standard and providing cGMP guidance/information on new/proposed regulations and strategies for Compliance

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Lead and develop a group of individuals who are proficient in executing Compliance activities for Sharp.
• Is the primary Compliance contact during audit/inspection activities (customer, internal and regulatory).
• Participate in regulatory inspections and co-ordinate follow-up. Engage appropriate Quality and Operations employees as required.
• Manage an internal audit program that includes establishing an annual audit plan, conducting the audits, and monitoring progress of follow-up actions. Engage appropriate Site Quality employees and Operations employees as required.
• Lead a supplier quality management program that includes qualifying new suppliers, maintaining supplier audit schedules and an approved supplier list, measuring supplier quality performance, and driving a certified supplier program.
• Manage day-to-day activities of the FDA Compliance program at Sharp and ensure compliance with all federal and state regulations. Coordinate and support all FDA and DEA-regulated activities for Sharp operations: tracking, recording, monitoring, and regulatory reporting of all movements of controlled substances from receiving, manufacturing, packaging, distribution departments.
• Prepare and submit periodic reports for the DEA (ARCOS, YERS, etc.). Ensure that proper licenses and registrations are maintained to receive, manufacture, package, ship product, importer, and exporter.
• Coordinate all year-end physical inventory activities for the submission of DEA Licenses including discrepancy investigations, balancing inventories for transfers, shipments, receipts and destructions to reconcile the drug within the allowable accountability percentage.
• Manage the compilation of customer-specific data for annual product review purposes.
• Compile and review Quality/Technical Agreements with/for customers.
• Maintain licensing and facility registrations including and provide assistance to Sharp’s foreign facilities, as needed.
• Manage client regulatory requests including review of filing information, regulatory application assistance etc.
• Establish and maintain Drug Listings as required.
• Coordinate, as appropriate, problem-solving initiatives to address customer or regulatory quality issues.
• Establishing new procedures as required based on client or regulatory needs.
• Identify new compliance trends, regulatory agency changes and strategies to keep the company in good standing.
• Direct supervision of compliance, audit groups, FDA, and DEA activities for the company. Hires and develops individuals to ensure a highly performing Compliance team.

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, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE:

• B.S. degree preferably in science related field.
• 10 years of experience in a biopharmaceutical-related, cGMP manufacturing and/or packaging company or related industry. Some exposure to combination products is an advantage.
• 5 years of direct supervisory experience of technical professionals; has demonstrated effectiveness with recruiting and training a team as well as providing continued guidance, mentorship, and support to staff.
• Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections.
• Strong knowledge and application of the cGMPs; experience of involvement in multiple regulatory inspections (familiar with multiple regulatory jurisdictions both domestically and international) and experience reviewing and/or authoring regulatory filings is a plus.
• Experience leading both internal and external supplier audits, identifying deficiencies, driving resolution, and ensuring audit closure.
• Ability to synthesize data and summarize outcomes to provide recommendations on a Compliance path forward.
• Demonstrated ability to perform long-term project planning, drive team building, maintain practical budgeting and drive operational excellence.

LANGUAGE SKILLS:

• Excellent oral and written communication skills with strong technical writing experience.
• Ability to read and interpret common scientific data. Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community and colleagues.

REASONING ABILITY:

Ongoing contact with internal Operations, Sales, Engineering, and Quality Department employees, plus customer QA representatives. Contact with regulatory personnel concerning compliance with customer requirements as well as cGMP’s. Customers agreements and regulatory guidelines are available to assist, however frequent review and reasonable interpretation are necessary to keep current. Good mental skills for analysis and problem solving are needed. Need an ability to negotiate to reach a common solution meeting everyone’s needs.

CERTIFICATES, LICENSES, REGISTRATIONS:

Must be proficient in Microsoft Office Suite.

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.

The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

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.

While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor. The working environment is clean and not normally subject to hazardous environment or conditions.

Travel to customers on an as needed basis.

Job Type: Full-time

Pay: From $150,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Experience level:

• 10 years

Schedule:

• 8 hour shift
• Monday to Friday

Experience:

• Quality Compliance: 8 years (Preferred)
• Customer Audits: 8 years (Preferred)
• FDA regulations: 8 years (Preferred)

Work Location: In person